Status:
RECRUITING
Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
Lead Sponsor:
Peking University First Hospital
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with th...
Detailed Description
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with th...
Eligibility Criteria
Inclusion
- Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC);
- High-risk UTUC: \>= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition);
- Aged \>= 18 years old;
Exclusion
- With Distant metastases already found at the time of surgery; non-R0 resected ;
- History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
- Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception;
- History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years);
- Weight loss \> 10% within 6 months;
- Existing or coexisting bleeding disorders, active infection;
- Terrible condition cannot tolerate the intervention;
- Unable to sign informed consent due to psychological, family, social and other factors.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 8 2029
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06120374
Start Date
January 1 2022
End Date
June 8 2029
Last Update
December 30 2025
Active Locations (3)
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1
Departmeng of Urology, Peking University First Hospital
Beijing, China
2
Department of Medical Oncology, Peking University First Hospital
Beijing, China
3
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China