Status:

RECRUITING

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Lead Sponsor:

Peking University First Hospital

Conditions:

Radiation Therapy

Targeted Therapy

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 20 2028

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06889649

Start Date

January 1 2019

End Date

February 20 2028

Last Update

March 21 2025

Active Locations (1)

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Peking University First Hospital

Beijing, Beijing Municipality, China, 100034