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NCT06889649

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Recruiting now Phase 2 Last updated 21 March 2025
What this trial tests

Phase 2 trial testing Stereotactic Ablative Body Radiotherapy (SABR) in Radiation Therapy in 30 participants. Currently enrolling.

Timeline
1 January 2019
Primary endpoint
28 February 2027
20 February 2028

Quick facts

Lead sponsorPeking University First Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 January 2019
Primary completion28 February 2027
Estimated completion20 February 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University First Hospital

Who can join

Adults 18 to 80, any sex, with Radiation Therapy or Targeted Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent progress on tyrosine kinase inhibitors resistance in renal cell carcinoma: another brick in the wall?
    Dong Z, Li S, Li M, Fan M, et al · · 2025 · cited 1× · PMID 41281942 · DOI 10.20517/cdr.2025.157
  2. 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.
    Hu K, Ma MW, Gao XS, Li HZ, et al · · 2025 · PMID 40503038 · DOI 10.3892/ol.2025.15122

Verify or expand the search:

Other trials of Stereotactic Ablative Body Radiotherapy (SABR)

Trials testing the same drug.

Other recruiting trials for Radiation Therapy

Currently open trials in the same condition.

Other Peking University First Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06889649.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing