Upper Tract Urothelial Carcinoma (UTUC)
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willingness to participate in the study, intention for long-term treatment, provision of signed informed consent, good participant compliance, and willingness to cooperate with follow-up. 2. Age >= 18 years. 3. Histologically or cytologically confirmed diagnosis of Upper Tract Urothelial Carcinoma (UTUC) and having undergone nephroureterectomy. 4. Postoperative staging of pT2-pT4 pN0-2 M0 or pTany N1-2 M0; patients with microscopically positive pathological margins are eligible. 5. If lymph node involvement was identified during preoperative imaging or surgery, resection of significantly abnormal lymph nodes must have been performed. 6. Postoperative imaging shows no evidence of residual significant lymph node lesions. 7. Suitable for and willing to receive adjuvant chemotherapy, with the first cycle starting within 90 days after radical nephroureterectomy. 8. Completion of at least 2 cycles of postoperative platinum-based chemotherapy with confirmed absence of disease recurrence/progression after chemotherapy. 9. Patients are allowed if they have treatment-related alopecia (any grade), CTCAE Grade 1 fatigue, or stable peripheral neuropathy (= 3,000/µL Hemoglobin (Hb) >= 9 g/dL Platelet count (PLT) >= 100,000/µL Hepatic Function: Total Bilirubin (TBil) = 3 g/dL Renal Function (meeting any one of the following): Serum Creatinine (SCr) = 30 mL/min; 11. Eastern Cooperative Oncology Group (ECOG) performance status = 12 months.
Exclusion criteria
Exclusion criteria: 1. Patients with tumors containing only components such as adenocarcinoma, squamous cell carcinoma, or neuroendocrine carcinoma, and lacking any urothelial carcinoma component (i.e., pure non-urothelial carcinoma types) should be excluded. 2. Presence of identified distant metastasis. 3. Postoperative imaging confirms the presence of residual significant abnormal lymph node lesions. 4. Diagnosis of concurrent muscle-invasive bladder cancer. Note: Patients with concurrent non-muscle-invasive bladder cancer (NMIBC) are NOT excluded. 5. Severe comorbidities that may interfere with the study protocol. 6. Severe autoimmune diseases. 7. Severe cardiovascular or cerebrovascular diseases. 8. Severe active infections. 9. Poorly controlled severe hypertension or diabetes mellitus. 10. Active HBV or HCV infection (HBsAg positive with HBV DNA >= 2000 IU/mL, or HCV antibody positive with HCV RNA above the lower limit of quantification). 11. Active tuberculosis or inadequately treated tuberculosis infection. 12. History of hypersensitivity or intolerance to any drug involved in the study. 13. Pregnant or lactating women, women of childbearing potential, and sexually active males who are unwilling or unable to use adequate non-hormonal contraceptive measures. 14. Presence of other progressive or recurrent malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Candidate Predictive Biomarker; CPB;Metastasis-Free Survival; MFS;Overall Survival; OS;Safety;second primary tumor in bladder, SPT;Patient-Reported Outcomes; PRO; | — |
Countries
China
Contacts
Public ContactHuang Hang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed