Combining radiation therapy with targeted and immunotherapy for advanced kidney cancer
Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma
PHASE2 · Peking University First Hospital · NCT06889649
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital (other) |
| Drugs / interventions | Toripalimab, Axitinib, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06889649 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of certain prior therapies, autoimmune diseases, or other malignancies may not benefit from this study.
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 performed: Other studies have shown promising results with similar combinations of targeted and immunotherapy, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiation Therapy, Targeted Therapy, Immunotherapy, Renal Cancer Metastatic