Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial

Condition: Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06257017

Sponsor: Yung NA

Phase: Phase 2


  • Age: minimum 18 Years maximum 70 Years
  • Gender: All

Inclusion Criteria:

  • 1. aged 18-70 years old; 2. a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status; 3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy; 4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma; 5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0; 6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment; 7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
  • ANC≥1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
  • WBC counts > 2500 cells/μL
  • Lymphocyte count ≥ 300 cells/μL
  • Platelet count ≥ 100,000 cells/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
  • Hemoglobin ≥ 9.0 g/dL
  • AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),
  • PTT ≤ 1.5 × ULN
  • PT ≤ 1.5 × ULN or INR < 1.7
  • Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula) 8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent

Exclusion Criteria:

  1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
  2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
  3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
  4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function;
  5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;
  6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;
  7. pregnancy or breastfeeding.

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