SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with recurrent or metastatic renal cell carcinoma (RCC), which is a type of kidney cancer that has spread to other parts of the body. The study combines three therapies: a type of radiation called stereotactic ablative body radiotherapy (SABR), a targeted therapy called Axitinib, and an immunotherapy called Toripalimab. The goal is to see if this combination is more effective in controlling the cancer and improving patients' overall survival compared to existing treatments.

To participate in the trial, patients must be between 18 and 80 years old and have confirmed RCC with a limited number of metastatic lesions suitable for treatment. They should also have a good performance status, meaning they can carry out daily activities with some limitations. Participants can expect to receive the three treatments together, and the research team will closely monitor their health for any side effects. This trial is currently recruiting participants, and it aims to find a potentially better treatment option for those facing this challenging disease.

Gender

ALL

Eligibility 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.