At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions
- ✓Age 18-80 years
- ✓Expected survival ≥12 weeks
- ✓Measurable disease by RECIST v1.1
- ✕Prior anti-PD-1 or PD-L1 antibody therapy
- ✕Prior radiotherapy
- ✕Corticosteroids or immunosuppressants within 14 days
- ✕Autoimmune diseases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Stereotactic Ablative Body Radiotherapy (SABR), TORIPALIMAB INJECTION(JS001 ), and 1 other intervention for Radiation Therapy and 3 related conditions. Currently recruiting, targeting 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied.
Toripalimab (intravenous infusion): Dosage: 240 mg intravenously every 3 weeks. Frequency: Administered every 3 weeks for the duration of the study, until progression or unacceptable toxicity occurs or reach 2 years.
Axitinib (oral, tablet): Dosage: 5 mg orally twice daily. Frequency: Daily, for the duration of the study, with continuation during progression or until intolerable side effects occur.