SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma

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.

Inclusion Criteria:

1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
2. Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or >5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.
3. Age between 18-80 years.
4. Expected survival of ≥12 weeks.
5. Measurable disease based on RECIST Version 1.1.
6. ECOG performance status of 0-2.

Exclusion Criteria:

1. History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.
2. Use of corticosteroids or other immunosuppressants within 14 days before treatment.
3. Autoimmune diseases.
4. History of other malignancies.
5. History of surgery within 28 days before treatment.
6. Allergy to study drug components.