Combining immunotherapy and radiotherapy after surgery for advanced ureter cancer
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study
This study is testing if combining a new immune treatment with radiation after surgery can help people with advanced ureter cancer do better than just having surgery alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, tirilizumab, Tirelizumab |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT06598761 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to evaluate the safety and efficacy of postoperative adjuvant immunotherapy combined with radiotherapy compared to surgery alone in patients with locally advanced upper tract urothelial carcinoma (UTUC). Patients who have undergone radical nephroureterectomy and have specific cancer characteristics will be enrolled. The study will involve two groups: one receiving immunotherapy with tirilizumab and radiotherapy, and the other receiving no additional treatment post-surgery, with regular monitoring. The goal is to determine if the combination therapy improves outcomes for patients who cannot tolerate chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 80 who have undergone radical nephroureterectomy for UTUC and have specific cancer staging characteristics.
Not a fit: Patients with distant metastasis or those who have other malignant diseases within the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that enhances recovery and survival rates for patients with advanced UTUC.
How similar studies have performed: While the combination of immunotherapy and radiotherapy is being explored in various cancers, this specific approach in UTUC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, AJCC staging (8th edition) containing one of the following factors: pT3-4, pN+; 2) Patients with creatinine eGFR \<60 min/L. or underlying disease refusing to tolerate chemotherapy. 3)18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent. All of the above need to be fulfilled: Expected survival \> 6 months; KPS \> 70 points; Leukocytes ≥ 3.5 x 109/l,Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100.0 x 109/l, Haemoglobin ≥ 90g/l. Exclusion Criteria: * 1\) Distant metastases already found at the time of surgery; non-R0 resected patients 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) Pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) History of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss \> 10% within 6 months 6) Presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, New York Heart Association (NYHA) class ≥ II congestive heart failure, unstable symptomatic arrhythmia, or class ≥ II peripheral vascular disease); 8) Psychological, family, and social factors leading to lack of informed consent.
Where this trial is running
Beijing and 1 other locations
- Departmeng of Urology, Peking University First Hospital — Beijing, China (Recruiting)
- Department of Radiotherapy Oncology, Peking University First Hospital — Beijing, China (Recruiting)
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.