Compares radioimmunotherapy with chemotherapy after surgery for upper urinary tract cancer
Observes outcomes of radiation plus immunotherapy versus chemotherapy in high-risk urothelial cancer patients.
Key facts
- Who runs it
- Peking University First Hospital
- Where
- Beijing, ChinaSee the 3 sites
- Trial code
- Registry title
- Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
- Status
- Recruiting
- People taking part
- 178 people, planned
- Started
- 1 Jan 2022
- Expected to end
- 8 Jun 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Radiotherapy
- Chemotherapy
- Immunotherapy
- Record updated
- 30 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks at people aged 18 or older who had surgery for upper urinary tract urothelial cancer and have a high risk of the cancer coming back. It compares radiotherapy with immunotherapy to chemotherapy.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Upper urinary tract urothelial carcinoma with high-risk features: stage pT2 or higher, lymph node spread (pN+), tumour grade G3, more than one tumour, or cancer cells at the cut edge of the surgery.
- Earlier treatment
- People with earlier radiotherapy to the pelvis or abdomen, or earlier chemotherapy given through the body, cannot join.
Main reasons for not taking part
- Cancer already spread to distant organs at the time of surgery, or surgery that did not remove all the tumour
- Earlier radiotherapy to the pelvis or abdomen, earlier chemotherapy given through the body, or inflammatory bowel disease
- Pregnant or breastfeeding women, or women who could become pregnant and do not use reliable contraception
- Another cancer in the past, except non-melanoma skin cancer, cervical cancer in situ, or tumours gone for more than 5 years
- Weight loss of more than 10% within 6 months, a bleeding disorder, or an active infection
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in China
- Departmeng of Urology, Peking University First HospitalBeijing, ChinaContact: Xuesong Li, M.D.Taking people
- Department of Medical Oncology, Peking University First HospitalBeijing, ChinaContact: Shikai Wu, M.D.Taking people
- Department of Radiotherapy Oncology, Peking University First HospitalBeijing, ChinaContact: Xianshu Gao, M.D.Taking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Adjuvant radioimmunotherapy
Participants underwent adjuvant radioimmunotherapy
Treatment: Radiotherapy and Immunotherapy
- Adjuvant chemotherapy
Participants underwent radical total nephroureterectomy and adjuvant chemotherapy
Treatment: Chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study
- Plain-language title
- Compares radioimmunotherapy with chemotherapy after surgery for upper urinary tract cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 December 2025