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.

View trial on ClinicalTrials.gov