Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
| Renal Cancer Metastatic | — | UNRESOLVED | — |
| Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib (VEGF-TKI) | Drug | Axitinib | ALIAS |
| Stereotactic Ablative Body Radiotherapy (SABR) | Radiation | — | UNRESOLVED |
| TORIPALIMAB INJECTION(JS001 ) | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Therapy: SABR + Axitinib + Toripalimab
- description
- Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab. SABR: 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. Treatment duration is 1-5 weeks based on lesion location. Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects. Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity. Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met
- interventionNames
- Radiation: Stereotactic Ablative Body Radiotherapy (SABR)
- Drug: TORIPALIMAB INJECTION(JS001 )
- Drug: Axitinib (VEGF-TKI)
Primary outcomes (1)
- measure
- Progression-Free Survival 1 (PFS1)
- timeFrame
- From the start of SABR treatment to the first disease progression, up to 2 years. This primary endpoint assesses how long patients survive without disease progression while receiving the combination therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHu 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. PMID 40503038