Actively Recruiting
SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
Led by Peking University First Hospital · Updated on 2025-03-21
30
Participants Needed
1
Research Sites
476 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
- Patients with 5 or fewer metastatic lesions suitable for complete radiotherapy coverage; or more than 5 lesions with at least 3 suitable for radiotherapy as evaluated by radiotherapy and imaging departments.
- Age between 18 and 80 years.
- Expected survival of at least 12 weeks.
- Measurable disease based on RECIST Version 1.1.
- ECOG performance status of 0 to 2.
You will not qualify if you...
- History of anti-PD-1 or PD-L1 antibody therapy, or prior radiotherapy.
- Use of corticosteroids or other immunosuppressants within 14 days before treatment.
- Presence of autoimmune diseases.
- History of other malignancies.
- Surgery within 28 days before treatment.
- Allergy to any components of the study drugs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here