NCT06889649 SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
| NCT ID | NCT06889649 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University First Hospital |
| Condition | Radiation Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2019-01-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging. 2. 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. 3. Age between 18-80 years. 4. Expected survival of ≥12 weeks. 5. Measurable disease based on RECIST Version 1.1. 6. ECOG performance status of 0-2. Exclusion Criteria: 1. History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy. 2. Use of corticosteroids or other immunosuppressants within 14 days before treatment. 3. Autoimmune diseases. 4. History of other malignancies. 5. History of surgery within 28 days before treatment. 6. Allergy to study drug components.
Frequently Asked Questions
Who can join the NCT06889649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Radiation Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06889649 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06889649 currently recruiting?
Yes, NCT06889649 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University First Hospital to inquire about joining.
Where is the NCT06889649 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06889649 clinical trial?
NCT06889649 is sponsored by Peking University First Hospital. The trial plans to enroll 30 participants.