Combining radiation therapy with targeted and immunotherapy for advanced kidney cancer
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
Run by Peking University First Hospital · NCT06889649 · Data updated 2026-11-12
This study is testing a new treatment that combines radiation therapy with two other medications to see if it helps people with advanced kidney cancer live longer without their disease getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | Toripalimab, Axitinib, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | February 28, 2027 |
| Study ends | February 20, 2028 |
| Registry record updated | March 21, 2025 |
| Trial ID | NCT06889649 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with confirmed recurrent metastatic renal cell carcinoma and a limited number of lesions suitable for radiotherapy.
✕Probably not a fit
Patients with a history of certain prior therapies, autoimmune diseases, or other malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and effectiveness of a treatment regimen that combines stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Participants will receive these therapies to assess their impact on progression-free survival and other clinical outcomes. The study aims to determine if this combination can provide better results compared to existing treatments. Adverse events will be monitored to ensure patient safety throughout the trial.
Why it matters
Potential benefit: If successful, this treatment combination could improve survival rates and quality of life for patients with recurrent metastatic RCC.
How similar studies have gone: Other studies have shown promising results with similar combinations of targeted and immunotherapy, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.