尿路上皮癌是全球最常见的癌症之一。术后患者预后较差，估计五年疾病特异性生存率为50%。为改善总生存期及降低复发风险，化疗被推荐为标准治疗。

适应症：Muscle Invasive Bladder Urothelial Carcinoma、Muscle-Invasive Bladder Carcinoma

入组条件

aged 18-70 years old;
a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;
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;
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)
able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent

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

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。

监测循环肿瘤DNA中的基因特征以指导尿路上皮癌的辅助化疗