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NCT06889649
SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
Phase 2 trial testing Stereotactic Ablative Body Radiotherapy (SABR) in Radiation Therapy in 30 participants. Currently enrolling.
28 February 2027
Quick facts
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2019 |
| Primary completion | 28 February 2027 |
| Estimated completion | 20 February 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Stereotactic Ablative Body Radiotherapy (SABR)
- TORIPALIMAB INJECTION(JS001 ) — full drug profile →
- Axitinib (VEGF-TKI) — full drug profile →
Conditions studied
- Radiation Therapy — all drugs for Radiation Therapy →
- Targeted Therapy — all drugs for Targeted Therapy →
- Immunotherapy — all drugs for Immunotherapy →
- Renal Cancer Metastatic — all drugs for Renal Cancer Metastatic →
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):
-
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 -
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:
- PubMed search for NCT06889649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Peking University First Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06889649 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University First Hospital
- Last refreshed: 21 March 2025
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.
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