SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Peking University

Status and phase: Enrolling; Phase 2

Conditions: Radiation Therapy; Targeted Therapy; Immunotherapy; Renal Cancer Metastatic

Treatments: Radiation: Stereotactic Ablative Body Radiotherapy (SABR); Drug: TORIPALIMAB INJECTION(JS001 ); Drug: Axitinib (VEGF-TKI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06889649

PKUFH-RCC-SABR-001

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Combination Therapy: SABR + Axitinib + Toripalimab

Experimental group

Description:

Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab. 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. Treatment duration is 1-5 weeks based on lesion location. Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects. Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity. Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met

Treatment:

Drug: Axitinib (VEGF-TKI)

Drug: TORIPALIMAB INJECTION(JS001 )

Radiation: Stereotactic Ablative Body Radiotherapy (SABR)