尿路上皮癌是全球最常見的癌症之一。術後患者預後較差，估計五年疾病特異性存活率為50%。為改善整體存活期及降低復發風險，化療被推薦為標準治療。

適應症：Muscle Invasive Bladder Urothelial Carcinoma、Muscle-Invasive Bladder Carcinoma

收案條件

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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。

監測循環腫瘤DNA中的基因特徵以指導尿路上皮癌的輔助化療