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Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Key facts

Where
Beijing, KínaSee the 3 sites

Where in Kína

  • Departmeng of Urology, Peking University First HospitalBeijing, KínaTaking people
  • Department of Medical Oncology, Peking University First HospitalBeijing, KínaTaking people
  • Department of Radiotherapy Oncology, Peking University First HospitalBeijing, KínaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Peking University First Hospital
Trial code
NCT06120374
Record updated
2025. december 30.
Original 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 the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.Read full original descriptionShow less

Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

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 the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

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; 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); Existing or coexisting bleeding disorders, active infection; Terrible condition cannot tolerate the intervention; Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; Weight loss > 10% within 6 months; Unable to sign informed consent due to psychological, family, social and other factors.

ClinicalTrials.gov NCT06120374