SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

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.

Timeline

Start

2019-01-01

Primary completion

2027-02-28

Completion

2028-02-20

Publications

• Hu K, Ma MW, Gao XS, Li HZ, Chen JY, Li XY, Qin SB, Ren XY. Efficacy and safety of SABR/partial-SABR combined with axitinib and toripalimab in recurrent or metastatic renal cell carcinoma: Preliminary results from a prospective phase 2 trial. Oncol Lett. 2025 Jun 2;30(2):376. doi: 10.3892/ol.2025.15122. eCollection 2025 Aug.

Drugs

Indications