Clinical Trial

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Recruiting Phase 2
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Summary
This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.
Trial Details
NCT Number NCT06889649
Lead Sponsor Peking University First Hospital
Conditions Radiation Therapy, Targeted Therapy, Immunotherapy, Renal Cancer Metastatic
Enrollment 30 participants
Start Date 2019-01-01
Primary Completion 2027-02-28 (estimated)
Study Completion 2028-02-20 (estimated)
Updated on ClinicalTrials.gov 2025-03-21