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SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

NCT06889649 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-21

No results posted yet for this 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.

Conditions

  • Radiation Therapy
  • Targeted Therapy
  • Immunotherapy
  • Renal Cancer Metastatic

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2027-02-28
Completion
2028-02-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889649 on ClinicalTrials.gov