SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Last updated: March 19, 2025
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Vaccines

Urothelial Tract Cancer

Urothelial Cancer

Treatment

Stereotactic Ablative Body Radiotherapy (SABR)

TORIPALIMAB INJECTION(JS001 )

Axitinib (VEGF-TKI)

Clinical Study ID

NCT06889649
PKUFH-RCC-SABR-001
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesionsconfirmed by PET/CT or other systemic imaging.

  2. Patients with ≤5 metastatic lesions amenable to complete lesion coverageradiotherapy; or >5 lesions with at least 3 suitable for radiotherapy as evaluatedby 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

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.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Stereotactic Ablative Body Radiotherapy (SABR)
Phase: 2
Study Start date:
January 01, 2019
Estimated Completion Date:
February 20, 2028

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

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