Comparing radioimmunotherapy and chemotherapy for high-risk urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambispective cohort observational study aims to analyze the efficacy of adjuvant radioimmunotherapy, which combines radiotherapy and immunotherapy, compared to adjuvant chemotherapy in patients with upper urinary tract urothelial carcinoma who have high-risk factors. The study focuses on patients with postoperative pathology indicating pT2 or higher, N+, high-grade tumors, multiple tumors, or positive surgical margins. A subgroup analysis will identify which patients may benefit most from these different treatment approaches, ultimately aiming to improve outcomes for those at high risk for recurrence or metastasis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Departmeng of Urology, Peking University First Hospital
  Beijing, China Recruiting
• Department of Medical Oncology, Peking University First Hospital
  Beijing, China Recruiting
• Department of Radiotherapy Oncology, Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Xiaoying Li, M.D. — Department of Radiotherapy Oncology, Peking University First Hospital
• Study coordinator: Xuesong Li, M.D.
• Email: pineneedle@sina.com
• Phone: +86-15801399116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.