NCT06120374Recruiting
Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 178 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 1 Jan 2022
- Primary completion date
- 8 Jun 2027
- Lead sponsor
- Peking University First Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06120374
What you commit to
- Study type: Observational
- Planned participants: 178
- From 1 Jan 2022 to the primary completion date, 8 Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- With Distant metastases already found at the time of surgery; non-R0 resected ;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiotherapy Oncology, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Department of Medical Oncology, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Departmeng of Urology, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.