Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma

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