RecruitingPhase 2NCT06889649

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma

Sponsor

Peking University First Hospital

Enrollment

30 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Targeted Therapy Immunotherapy Radiation Therapy Renal Cancer Metastatic

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining stereotactic ablative radiation (SABR — a very precise, high-dose radiation that destroys tumors) with two drugs (axitinib and toripalimab, a targeted therapy and an immunotherapy) for people with kidney cancer that has come back or spread to other parts of the body. **You may be eligible if...** - You have confirmed kidney cancer (renal cell carcinoma) that has relapsed or spread - You have 5 or fewer metastatic sites that can be targeted with radiation, or more than 5 with at least 3 suitable for radiation - You are between 18 and 80 years old - You have measurable disease and are expected to survive at least 12 weeks - Your physical performance is adequate (ECOG 0–1) **You may NOT be eligible if...** - You have autoimmune disease that could worsen with immunotherapy - You have already received the same type of drugs - You have uncontrolled blood pressure or serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Ablative Body Radiotherapy (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.

DRUGTORIPALIMAB INJECTION(JS001 )

Toripalimab (intravenous infusion): Dosage: 240 mg intravenously every 3 weeks. Frequency: Administered every 3 weeks for the duration of the study, until progression or unacceptable toxicity occurs or reach 2 years.

DRUGAxitinib (VEGF-TKI)

Axitinib (oral, tablet): Dosage: 5 mg orally twice daily. Frequency: Daily, for the duration of the study, with continuation during progression or until intolerable side effects occur.