Comparing radioimmunotherapy and chemotherapy for high-risk urothelial carcinoma
Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study
This study is testing whether a new treatment that combines radiation and immune therapy works better than traditional chemotherapy for patients with high-risk bladder cancer after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT06120374 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of high-risk upper urinary tract urothelial carcinoma.
Not a fit: Patients with distant metastases at the time of surgery or those with a history of certain medical conditions or treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with high-risk urothelial carcinoma, potentially reducing recurrence and improving survival rates.
How similar studies have performed: While there have been studies on adjuvant therapies for urothelial carcinoma, the specific combination of radioimmunotherapy in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.