A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer

The goal of this clinical trial is to learn if the drug toripalimab (an anti-PD-1 antibody) works to prevent cancer recurrence in patients with high-risk renal cell carcinoma after they have had surgery to remove the kidney (nephrectomy). The study will also learn about the safety of toripalimab in this setting.The main questions the study aims to answer are: 1. Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment? 2. What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery. Participants in this study will: 1. Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses). 2. Visit the clinic regularly for check-ups, which will include: Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence. Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.

NCT Number	NCT06584435
Lead Sponsor	Tianjin Medical University Second Hospital
Conditions	High-risk Renal Cell Carcinoma
Enrollment	100 participants
Start Date	2022-10-10
Primary Completion	2025-11-01 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-19