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Recruiting NCT06889649

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Phase II Interventional Radiation Therapy Targeted Therapy Immunotherapy Renal Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Ablative Body Radiotherapy (SABR), TORIPALIMAB INJECTION(JS001 ), Axitinib (VEGF-TKI).
Who it may be relevant to
Registry conditions: Radiation Therapy, Targeted Therapy, Immunotherapy, Renal Cancer Metastatic. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Radiation 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.
  • Drug 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.
  • 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.

Primary outcome measures

  • Progression-Free Survival 1 (PFS1) [Time frame: From the start of SABR treatment to the first disease progression, up to 2 years. This primary endpoint assesses how long patients survive without disease progression while receiving the combination therapy.]
Secondary outcome measures (2)
  • Overall Survival (OS) [Time frame: From the start of treatment to death or until the end of the study (up to 3 years). This secondary endpoint will help evaluate the overall survival benefits of the combined treatment over a longer period.]
  • Progression-Free Survival 2 (PFS2) [Time frame: From the start of SABR treatment to the initiation of next-line treatment or death (an average of 3 year)]

Eligibility criteria

Inclusion criteria

  • Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
  • 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.
  • Age between 18-80 years.
  • Expected survival of ≥12 weeks.
  • Measurable disease based on RECIST Version 1.1.
  • ECOG performance status of 0-2.

Exclusion criteria

  • History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.
  • Use of corticosteroids or other immunosuppressants within 14 days before treatment.
  • Autoimmune diseases.
  • History of other malignancies.
  • History of surgery within 28 days before treatment.
  • Allergy to study drug components.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Publications

  • 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. PMID 40503038

Identifiers

NCT: NCT06889649 · PKUFH-RCC-SABR-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗