Tests radiation, axitinib and toripalimab together for kidney cancer that has spread
Tests radiation with two drugs in adults with kidney cancer that returned or spread.
Key facts
- Who runs it
- Peking University First Hospital
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 30 people, planned
- Started
- 1 Jan 2019
- Expected to end
- 20 Feb 2028
- Type of study
- Interventional
- Treatments tested
- Stereotactic Ablative Body Radiotherapy (SABR)
- TORIPALIMAB INJECTION(JS001 )
- Axitinib (VEGF-TKI)
- Record updated
- 21 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with kidney cancer (renal cell carcinoma) that has come back and spread. They would get axitinib, toripalimab and radiotherapy to the spread lesions.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Kidney cancer confirmed by tissue examination, with recurrent spread (metastases) confirmed by imaging. Up to 5 spread lesions that can be fully covered by radiotherapy, or more than 5 lesions with at least 3 that can have radiotherapy. Measurable disease by RECIST 1.1.
- Earlier treatment
- People who have had anti-PD-1 or PD-L1 antibody therapy or radiotherapy cannot join. No surgery in the 28 days before treatment.
Main reasons for not taking part
- Earlier anti-PD-1 or PD-L1 antibody therapy, or radiotherapy
- Steroids or other immune-suppressing drugs within 14 days before treatment
- Autoimmune disease
- History of another cancer
- Surgery within 28 days before treatment
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging
- 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
- Age between 18-80 years
- Expected survival of ≥12 weeks
- Measurable disease based on RECIST Version 1.1
- ECOG performance status of 0-2
Who cannot take part
- Use of corticosteroids or other immunosuppressants within 14 days before treatment
- History of surgery within 28 days before treatment
- History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy
- Autoimmune diseases
- History of other malignancies
- Allergy to study drug components
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Peking University First HospitalBeijing, ChinaContact: Mingwei MaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Combination Therapy: SABR + Axitinib + ToripalimabTreatment being tested
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
Treatment: Stereotactic Ablative Body Radiotherapy (SABR), TORIPALIMAB INJECTION(JS001 ), and Axitinib (VEGF-TKI)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma
- Plain-language title
- Tests radiation, axitinib and toripalimab together for kidney cancer that has spreadGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06889649, who can take part
- Record updated
- 21 March 2025