SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

NCT ID: NCT06889649

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2028-02-20

Brief 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.

Conditions

Radiation Therapy; Targeted Therapy; Immunotherapy; Renal Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy: SABR + Axitinib + Toripalimab

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

Group Type: EXPERIMENTAL

Stereotactic Ablative Body Radiotherapy (SABR)

Intervention Type: RADIATION

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.

TORIPALIMAB INJECTION(JS001 )

Intervention Type: DRUG

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.

Axitinib (VEGF-TKI)

Intervention Type: DRUG

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.

Interventions

Stereotactic 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.

Intervention Type: RADIATION

TORIPALIMAB 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.

Intervention Type: DRUG

Axitinib (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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Mingwei Ma

Role: primary

dr.mingweima@stu.pku.edu.cn

+86-15810160120

References

Hu K, Ma MW, Gao XS, Li HZ, Chen JY, Li XY, Qin SB, Ren XY. Efficacy and safety of SABR/partial-SABR combined with axitinib and toripalimab in recurrent or metastatic renal cell carcinoma: Preliminary results from a prospective phase 2 trial. Oncol Lett. 2025 Jun 2;30(2):376. doi: 10.3892/ol.2025.15122. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40503038 (View on PubMed)

Other Identifiers

PKUFH-RCC-SABR-001

Identifier Type: -

Identifier Source: org_study_id