Bladder Cancer

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Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies


Condition: Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Neoplasms, Ovarian Neoplasm, Advanced Solid Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04561362

Sponsor: BicycleTx Limited

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Key Inclusion Criteria:

  • Life expectancy ≥12 weeks.
  • Patients must have measurable disease per RECIST 1.1.
  • Part A-1 cohorts:
  • Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
  • Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample must be submitted); or
  • Patients with advanced, histologically confirmed pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumors that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing for Nectin-4 expression).
  • Part A-2:
  • Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
  • Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that have progressed following prior therapy
  • Cohort B-1: Histologically documented urothelial carcinoma, previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
  • Cohort B-2 and B-3: Histologically documented urothelial carcinoma, not previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
  • Cohort B-4: Patients with histologically confirmed non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria that have progressed following prior therapy.
  • Cohort B-5: Patients with triple-negative breast cancer confirmed negative for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) (i.e., triple-negative) that have progressed following prior therapy.
  • Cohort B-6: Patients with histologically confirmed non-small cell lung cancer (NSCLC) with no actionable mutations, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that have progressed following prior therapy.
  • Cohort B-7: Locally advanced or metastatic, histologically confirmed urothelial (transitional cell) carcinoma, ineligible for cisplatin, no prior systemic anticancer treatment for advanced urothelial carcinoma.
  • Cohort B-8: Locally advanced (unresectable) or metastatic, histologically confirmed breast cancer, either TNBC or hormone receptor (HR) positive and HER-2 negative according to ASCO/CAP guidelines and up to 3 prior lines of therapy for advanced (unresectable) or metastatic disease.
  • Cohort B-9: Histologically confirmed advanced/metastatic squamous or non-squamous NSCLC, negative for oncogenic driver mutations (EGFR, KRAS, ALK, BRAF, MET, ERRB2).
  • Cohort C renal insufficiency cohort: Patients with histologically documented urothelial carcinoma, ovarian, triple negative breast, or non-small cell lung cancer that have been previously treated with a locally approved therapy.
  • Part D supplementary PK: Patients must have histologically confirmed urothelial (transitional cell) carcinoma (patients with squamous differentiation or mixed cell types are eligible); ovarian; triple-negative breast; or non-small cell lung cancer that have been previously treated with a locally approved therapy.

Key Exclusion Criteria:

  • (all patients):
  • Clinically relevant troponin elevation
  • Uncontrolled diabetes
  • Known active or untreated CNS and/or carcinomatous meningitis
  • Grade ≥2 peripheral neuropathy
  • Active keratitis or corneal ulcerations
  • Patients with uncontrolled hypertension
  • History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions).
  • Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009.
  • Prior Stevens-Johnson syndrome/toxic epidermal necrolysis on any MMAE-conjugated drug
  • Parts A-2 and B-7 Pembrolizumab Combination Cohorts:
  • Prior organ transplant (including allogeneic)
  • Diagnosis of clinically relevant immunodeficiency
  • History of interstitial lung disease
  • Parts B-2 and B-3: Prior treatment with enfortumab vedotin Other protocol-defined Inclusion/

Exclusion Criteria:

  • may apply
  • Parts B-8 and B-9: Prior treatment with an ADC containing an MMAE (vedotin) payload.

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A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors


Condition: Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer, Ovarian Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Prostate Cancer, Renal Pelvis Cancer, Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06238479

Sponsor: Eli Lilly and Company

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Have one of the following solid tumor cancers:
  • Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
  • Cohort A2/B1/B2: urothelial carcinoma
  • Cohort C1: triple negative breast cancer
  • Cohort C2: non-small cell lung cancer
  • Cohort C3: ovarian or fallopian tube cancer
  • Cohort C4: cervical cancer
  • Cohort C5: head and neck squamous cell carcinoma
  • Prior Systemic Therapy Criteria:
  • Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
  • Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
  • Prior enfortumab vedotin specific requirements:
  • Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
  • Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  • Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  • Measurability of disease
  • Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  • Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

  • Individual with known or suspected uncontrolled CNS metastases
  • Individual with uncontrolled hypercalcemia
  • Individual with uncontrolled diabetes
  • Individual with evidence of corneal keratopathy or history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Current of history of intestinal obstruction in the previous 3 months
  • Recent thromboembolic event or bleeding disorder
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • History of pneumonitis/interstitial lung disease
  • History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
  • Individual with active uncontrolled infection

View trial on ClinicalTrials.gov


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A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors


Condition: Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer, Ovarian Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Prostate Cancer, Renal Pelvis Cancer, Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06465069

Sponsor: Eli Lilly and Company

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Have one of the following solid tumor cancers:
  • Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
  • Cohort A2/B1/B2: urothelial carcinoma
  • Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer
  • Prior Systemic Therapy Criteria:
  • Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
  • Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
  • Prior enfortumab vedotin specific requirements:
  • Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required
  • Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  • Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  • Measurability of disease
  • Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  • Cohorts A2, B1, B2, C: measurable disease required as defined by RECIST v1.1
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

  • Individual with known or suspected uncontrolled CNS metastases
  • Individual with uncontrolled hypercalcemia
  • Individual with uncontrolled diabetes
  • Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Recent thromboembolic event or bleeding disorder
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • History of pneumonitis/interstitial lung disease
  • History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

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A Phase 1a/b Study of ADRX-0706 in Subjects with Select Advanced Solid Tumors


Condition: Solid Tumors, Triple Negative Breast Cancer (TNBC), Urothelial Cancer, Cervical Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06036121

Sponsor: Adcentrx Therapeutics

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator.
  • Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the opinion of the investigator, unless subject refuses standard therapy.
  • Measurable disease according to RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, liver, and renal function

Exclusion Criteria:

  • Active and uncontrolled central nervous system metastases
  • Significant cardiovascular disease
  • History of another malignancy other than the one for which the subject is being treated on this study within 3 years
  • Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
  • Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
  • Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

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Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma


Condition: Urothelial Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05321316

Sponsor: Peking University Cancer Hospital & Institute

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. 18-75 years old, male or female;
  2. Heart function is normal;
  3. Normal heart function;
  4. Estimated survival ≥12 weeks;
  5. Good follow-up compliance;
  6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
  7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
  8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
  9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

  1. Serious abnormality of liver, kidney and blood;
  2. Pregnant patients;
  3. Pregnant and lactation women; 3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

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Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas


Condition: Urothelial Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06120413

Sponsor: Sichuan Provincial People's Hospital

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age 18 and above
  • No gender difference
  • Patients who have been diagnosed with, or are clinically highly suspected of, urothelial carcinomas and have had no other treatment within 3 months

Exclusion Criteria:

  • Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
  • Complicated with chronic liver disease, myocardial infarction, stroke
  • Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
  • Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

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A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)


Condition: High-Risk Non-Muscle-Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06567743

Sponsor: CG Oncology, Inc.

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Key Inclusion Criteria:

  • Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.
  • Participants with BCG-naïve NMIBC should have either:
  • No prior treatment with BCG OR
  • No treatment with BCG within the past 24 months prior to current pathological diagnosis OR
  • A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.
  • All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
  • Acceptable baseline organ function.

Key Exclusion Criteria:

  • Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
  • High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.
  • Significant immunodeficiency.
  • Pregnant or breastfeeding.

View trial on ClinicalTrials.gov


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A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)


Condition: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04452591

Sponsor: CG Oncology, Inc.

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • In order to be eligible for participation in this trial, the patient must:
  • Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG unresponsive CIS. Patients with BCG unresponsive CIS are those unlikely to benefit from, and who will not be receiving, further intravesical BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols (e.g., BCG weekly × 6 then weekly × 3 weeks administered at Months 3, 6, 12, 18, 24, and 36). Specifically, the definition of BCG unresponsive CIS will also require the following:
  • Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies).
  • Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time).
  • Pathological confirmation of BCG unresponsive CIS within 8 weeks of study enrollment.
  • CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
  • No maximum limit to the amount of BCG administered but maintenance BCG should be administered on a schedule consistent with the SWOG 8507 regimen (Lamm 2000).
  • Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment (e.g., prior to Day 1 treatment).
  • Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
  • Demonstrate adequate organ function
  • Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial Cohort P Inclusion Criteria
  • Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent
  • Have ECOG performance status of 0 to 2.
  • Have pathologically confirmed (WHO grading system employed for tumor grading) (Compérat 2019) BCG-unresponsive HG Ta/T1 papillary disease without CIS. Patients with BCG-unresponsive HG Ta/T1 papillary disease are those unlikely to benefit from and who will not be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive HG Ta/T1 papillary disease without CIS will also require the following:
  • Pathologically confirmed recurrent HG Ta/T1 papillary disease without CIS within 6 months of completion (last dose) of adequate BCG treatment for HGUC (e.g., CIS, HG Ta, HG T1, or a combination of these HGUC pathologies).
  • Patients with HG Ta: Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG (e.g., induction and initial maintenance or re-induction cycle must be completed over no more than a 12-month period of time).
  • Patients with HG T1: Patients may be eligible after the initial induction alone (5 of 6 doses of an induction course) as the qualifying BCG treatment.
  • Completion (last dose) of qualifying BCG treatment within 12 months of study enrollment.
  • Pathological confirmation of BCG-unresponsive HG Ta/T1 papillary disease without CIS within 14 days of study enrollment.
  • All pathology specimens must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
  • No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG
  • Have all Ta and/or T1 disease resected, prior to study treatment (e.g., prior to Day 1 treatment).
  • Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy based on Investigator assessment.
  • Demonstrate adequate organ function,
  • Patients must be willing to comply with study-mandated cystoscopies, urine cytology, imaging, biopsies, and other procedures for the duration of the trial Cohort C and Cohort P

Key Exclusion Criteria:

  • Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
  • Any HGUC as T1, HG Ta, or CIS in the upper genitourinary tract or prostatic urethra (including CIS of the urethra) within 24 months prior to enrollment OR any history of T2 or higher stage urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters).
  • Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1.
  • Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
  • Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
  • Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of cretostimogene.
  • IVE therapy within 8 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted 14 or more days prior to beginning study treatment

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Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06427824

Sponsor: University of Chicago

Eligibility:

  • Age: minimum 65 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Participants capable of giving consent
  • Participants undergoing radical cystectomy (both for curative and palliative intent) for bladder cancer diagnosed by tissue pathology with urinary diversion at the University of Chicago
  • Participants undergoing neoadjuvant chemotherapy will be included
  • Participants will be included regardless of gender, race or ethnicity
  • Participants greater than or equal to 65 years of age

Exclusion Criteria:

  • Radical cystectomy for non-oncologic indications
  • Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical)

View trial on ClinicalTrials.gov


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A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study


Condition: Bladder Cancer, Cystectomy, Chemotherapy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06002269

Sponsor: University of Utah

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Adult patients 18 years or older.
  2. Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute
  3. Have reliable, consistence access to the internet for study procedures Inclusion of Individuals across the Lifespan: The proposed trial will enroll 20 adults who have been diagnosed with bladder cancer. The age range of participants to be recruited is 18 years or older. Bladder cancer is generally a disease of older age and is exceedingly rare in children. According to the American Cancer Society, average age at diagnosis is 73.1 Therefore, we are unable to include children in this trial. Inclusion of Women, Minorities, and Children: It is anticipated that 20% will be female; 80% male. Racial distribution is projected to be as follows: 97% white, 1% Native Hawaiian or Pacific Islander; 1% American Indian/ Alaska Native; 1% Asian; <1% Black. Approximately 96% will be Non-Hispanic.

Exclusion Criteria:

  1. Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet).
  2. Unable to provide informed consent or read, write, or fill in questionnaires in English

View trial on ClinicalTrials.gov


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Artificial Intelligence Detection of Bladder Tumors Under Endoscopy


Condition: Bladder Tumor

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06474338

Sponsor: Peking Union Medical College Hospital

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  1. The patient who receives cystoscopy and the cystoscopy video is available, and one or multiple bladder lesions can be observed in the cystoscopy.

Exclusion Criteria:

  1. The patient whose cystoscopy is not clear enough to analyze.

View trial on ClinicalTrials.gov


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Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC


Condition: HER2 Positive or Suspicious Positive Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06548529

Sponsor: Peking University Cancer Hospital & Institute

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  1. Aged # 18 years old; ECOG 0 or 1;
  2. Is unresectable or metastatic;
  3. Patients with HER2 positive or suspicious positive tumors;
  4. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane;
  5. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
  6. Receives anti-HER2 ADC treatment
  7. Life expectancy > 3 months

Exclusion Criteria:

  1. Significant hepatic or renal dysfunction;
  2. Is pregnant or ready to pregnant;
  3. Cannot keep their states for half an hour;
  4. Refused to join the clinical research;
  5. Suffering from claustrophobia or other mental disorders;
  6. Any other situation that researchers considered it unsuitable to participate in the trial.

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Stereotactic Treatment with NeoAdjuvant Radiotherapy and Enfortumab Vedotin: a Phase I/II Study with Safety Lead-In for Localized, Cisplatin Ineligible, Muscle Invasive Bladder Cancer (STAR-EV)


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06394570

Sponsor: University of Texas Southwestern Medical Center

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Urothelial carcinoma of the urinary bladder stage cT2-4a (AJCC 8th edition) N0M0 planned for radical cystectomy. Mixed cell types are allowed as long as urothelial component is >50% AND no small cell/neuroendocrine or plasmacytoid/signet ring component. 2. Ineligibility for cisplatin-based chemotherapy based on treating physician assessment and any of the following "Galsky criteria": renal insufficiency (Creatinine Clearance <60ml/min by standard institutional calculation method), >=grade 2 peripheral neuropathy, >=grade 2 hearing loss, New York Heart Association (NYHA) class III heart failure; a combination of these; or patient refusal. 3. Age >=18. 4. Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 5. Adequate organ and marrow function as defined below: •Hematologic: -Absolute neutrophil count (ANC) >=1500/mm3
  • Platelet count >=100x109/L
  • Hemoglobin ≥ 9 g/dL •Hepatic:
  • Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN •Renal:
  • No end stage renal disease requiring dialysis allowed 6. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following completion of study neoadjuvant therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 7.Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer >12 prior to registration) for bladder cancer or prior pelvic radiotherapy. Prior intra-vesical therapies are allowed, including Bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer. Prior chemotherapy for other cancers is allowed if given >=1 year prior to study registration.
  2. Baseline >= Grade 2 sensory or motor neuropathy
  3. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to enfortumab vedotin or other agents used in study.
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
  6. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.


Condition: Urinary Bladder Neoplasms

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06403202

Sponsor: Lille Catholic University

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Major patient
  • Patient with suspected bladder cancer likely to be treated with chemotherapy
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Insufficient tumor volume
  • Patient under guardianship
  • Pregnant or breast-feeding women
  • Patient opposed to participation in the study

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Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer


Condition: Screening Tool, Focus Group

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06412874

Sponsor: Icahn School of Medicine at Mount Sinai

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 89 Years
  • Gender: All

Inclusion Criteria:

  • Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer
  • between 18 years and older (18-89 years)
  • have initiated any systemic treatment for advanced urothelial carcinoma
  • speak English speaking and are able to consent.

Exclusion Criteria:

  • Have a diagnosis of another advanced cancer that has required systemic therapy
  • Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.

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A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer


Condition: Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Unresectable Bladder Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06414317

Sponsor: Roswell Park Cancer Institute

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • PATIENTS: Age ≥ 18 years
  • PATIENTS: Metastatic or locally advanced, unresectable bladder cancer
  • PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC)
  • PATIENTS: Subjects can be enrolled any time from initial diagnosis of advanced disease to within 8 weeks after initiation of first-line systemic therapy for advanced bladder cancer
  • PATIENTS: Able to speak, understand, read, and write English
  • CAREGIVERS: Age ≥ 18 years
  • CAREGIVERS: Only caregivers of enrolled patients will be included in the study
  • CAREGIVERS: Should be able to speak, understand, read, and write English
  • CAREGIVERS: Caregivers will be enrolled in the genitourinary (GU) clinic during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)

Exclusion Criteria:

  • PATIENTS: Not receiving any form of systemic therapy for bladder cancer due to Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3, co-morbidities, or inadequate organ function
  • PATIENTS: Predominantly small cell histology
  • PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys
  • PATIENTS: Pregnant women
  • CAREGIVERS: Cognitively impaired adults/adults with impaired decision-making capacity
  • CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers)

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Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study


Condition: Urothelial Bladder Cancer, Muscle-Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06335667

Sponsor: University of California, Irvine

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age 18 years old or greater at the time of consent.
  • Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated urologist performing this procedure.
  • ECOG Performance Status of 0-3.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
  • Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.

Exclusion Criteria:

  • Prior TURBT within 120 days of study entry.
  • Prior therapy for bladder cancer within 120 days of study entry.
  • Inability to tolerate mpMRI or associated contrast.
  • Inability to tolerate TURBT or associated anesthesia.
  • ECOG Performance Status of 4.
  • Female patient who is known to be pregnant or breastfeeding.

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A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC)


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06427291

Sponsor: Fudan University

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Participants who understand and voluntarily sign the written ICF, and are willing and able to comply with all trial requirements. 2. Male or female, aged ≥ 18 years at the time of signing the ICF. 3. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Tis). 4. Participants with high risk NMIBC who have been diagnosed by cystoscopy, urine cytology, and histopathology within 8 weeks prior to the first dose administration and have failed or intolerant to BCG treatment after TURBT surgery, and are not suitable or willing to undergo radical cystectomy. 5. BCG-failure include BCG refractory, recurrence or relapsing after BCG treatment, BCG unresponsive and BCG intolerant. 6. All tumors should have no visible tumors after transurethral bladder tumor resection (TURBT). If meeting the requirements for secondary resection, secondary resection need to be done. It is recommended to perform secondary resection if the following conditions are met: the first TURBT is insufficient, there is no muscle tissue in the first resection specimen (excluding low-grade [Ta G1] tumors and pure in situ cancers), T1 stage tumors, and high-grade [G3] tumors (excluding pure in situ cancers); Secondary resection is recommended to be performed 2-6 weeks after the first resection; Participants undergoing secondary resection must meet the requirement of no visible tumors after surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 8. Expected survival ≥3 months. 9. Sufficient hematology and terminal organ function were met within 4 weeks prior to the first s treatment, for example, having sufficient bone marrow reserves and organ function:
  • Hematology (hematopoietic growth factor treatment or blood transfusion should not be given within 2 weeks prior to the treatment of study drug): ANC≥1.5×10^9/L, PLT count ≥75×10^9/L, Hemoglobin (HGB) ≥90 g/L.
  • Renal function: Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation)
  • Hepatic function: Serum total bilirubin (TBIL) ≤1.5×ULN, Aspertate aminotransferase (AST) and alanine transaminase (ALT) ≤3×ULN
  • Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated partial thromboplastin time (aPTT) ≤1.5×ULN 10. Women with fertility should agree to use contraceptive measures (such as intrauterine devices (IUDs), contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period. Note: A female subject with fertility is defined as a female subject who has not reached a postmenopausal state after menarche (continuous amenorrhea for at least 12 months, with no other clear cause other than menopause), and has not undergone surgery (i.e. bilateral ovariectomy, fallopian tube resection, and/or hysterectomy) or other causes determined by the researcher (such as underdeveloped Mullerian tubes) leading to permanent infertility.

Exclusion Criteria:

  • Patients meeting one or more of the following criteria will be excluded: 1. The diagnosis is confirmed as muscle invasive bladder cancer (T2-T4). 2. Patients with concurrent upper and lower urinary tract epithelial carcinoma, lymph node metastasis, or distant metastasis. 3. Pregnant and lactating female patients. 4. Having major surgery within 4 weeks prior to the first dose of the study drug, or anticipate the need for major surgery rather than diagnosis after enrolling the study. 5. In addition to immediate instillation therapy after TURBT surgery, anti-tumor drug treatments such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc. have been received within 4 weeks prior to the first dose of the study drug (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitrso urea or mitomycin C is within 6 weeks prior to the first use of the study drug, and oral fluorouracil and small molecule targeted drugs are within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer). Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of the study drug. 6. Patients who have received systemic corticosteroids (prednisone>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose of the study drug; Excluding the use of local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment; Short term use of corticosteroids for preventive treatment (such as preventing contrast agent allergies). 7. Taking live attenuated vaccines within 4 weeks prior to the first dose of the study drug, or it is expected that live attenuated vaccines will be vaccinated during the study period. 8. Participants who have previously received oncolytic virus therapy (such as T-vec, T3011, etc.), gene therapy, cell therapy, and tumor vaccines. 9. Participants have a history of splenectomy or organ transplantation. 10. Participants with the malignant tumors other than the disease treated in this study, except for the following:
  • Malignant tumors that have undergone treatment with the aim of cure, at least more than 5 years from the drug treatment, have no known active diseases, and have a low potential risk of recurrence;
  • Fully treated non-melanoma skin cancer or malignant freckle like nevi with no evidence of disease;
  • In situ cancer with sufficient treatment and no evidence of disease. 11. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and gross hematuria. 12. Indwelling ureteral stent or having a history of bladder ureteral reflux disease. 13. Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction within the first three months of enrollment, unstable arrhythmia or unstable angina. 14. Having the history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wagner's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except for patients with hypothyroidism or diabetes who have good control of alternative treatment. 15. Persistent or active infections exist, and drug treatment and control are still not ideal; Including but not limited to: active pulmonary tuberculosis, non negative AIDS virus (HIV) antibody, positive hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA) quantity ≥ the lower limit of the laboratory test in the research center, hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus RNA quantity ≥ the lower limit of the laboratory test in the research center. 16. Participants who require oral or intravenous use of anti herpesvirus drugs during the study period (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foxinkane, cedofovir, etc.) (excluding local use such as topical use). 17. Participants with the history of allergic reactions to HSV-1, IL-12, or anti PD-1 antibodies and similar biological components, or those known to have allergic reactions to any component of T3011. 18. Fever above 38.5 ℃ with no explained reason during the screening period, washout period/baseline period, or on the day of administration (the researcher determines that fever caused by tumors can be included), according to the researcher's judgment, may affect the patient's participation \in this trial or interfere with the evaluation of efficacy. 19. In the period of recurrent herpes simplex virus infection, there are corresponding clinical manifestations, such as lip herpes, herpetic keratitis, herpetic dermatitis, genital herpes, etc. 20. Participants who have previously developed non infectious pneumonia/interstitial pneumonia or are intolerant to immunotherapy drugs (including but not limited to anti PD-1/PD-L1 antibodies) (including but not limited to developing ≥ grade 3 immune related adverse events [irAEs]) (excluding endocrine related irAEs that can be stably controlled through hormone replacement therapy).

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Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion


Condition: Muscle-Invasive Bladder Carcinoma, Radical Cystectomy, Ileal Conduit, Neobladder Diversion

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06190197

Sponsor: University of Minnesota

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
  • 18 years of age or older

Exclusion Criteria:

  • Currently receiving antimicrobials for active infection
  • Poor renal function with GFR < 30 ml/min
  • Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
  • Pregnancy
  • Unable to provide Informed consent

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Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer


Condition: Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study, Treatment Outcome, Neoplasm Recurrence, Local

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06441110

Sponsor: Fujian Medical University Union Hospital

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. Voluntary participation in the trial with signed informed consent;
  2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
  3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);
  4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
  5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.

Exclusion Criteria:

  1. Any of the following conditions: Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;
  2. Concurrent urogenital system tumors or tumors in other organs;
  3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
  4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
  5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);
  6. Known or suspected intraoperative bladder perforation;
  7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;
  8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;
  9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;
  10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;
  11. Participation in other drug clinical trials within 3 months before enrollment;
  12. Known or suspected opioid or alcohol dependence;
  13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.

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