SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma (NCT07744932) | Clinical Trial Compass
RecruitingPhase 2
SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma
China48 participantsStarted 2026-08-15
Plain-language summary
This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites).
In this study, all metastatic tumors will be treated with SABR - a precise, high-dose radiation therapy delivered in 5 sessions. At the same time, participants will receive axitinib (an oral targeted cancer drug) twice daily, and toripalimab (an intravenous immunotherapy) every 3 weeks for up to 2 years.
The study will enroll 48 participants. The main goal is to measure the objective response rate - the proportion of patients whose tumors shrink or disappear after treatment. Researchers will also track how long patients live without their cancer worsening, overall survival, and any side effects from the treatment.
Participants will have regular imaging scans, blood tests, and quality-of-life assessments throughout the treatment and follow-up period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Radiological evidence of distant metastasis meeting the MD Anderson (MDA) definition of oligometastatic disease: ≤5 metastatic lesions, all amenable to curative-intent local therapy. Lesions must be measurable per RECIST 1.1 criteria.
Prior definitive local therapy to the primary tumor, including surgery, stereotactic radiotherapy, or ablation.
Either no prior systemic therapy for metastatic disease (first-line naïve), or prior first-line tyrosine kinase inhibitor (TKI) therapy only with subsequent oligoprogression (≤5 progressive lesions with remaining lesions stable).
Adequate organ function:
Hemoglobin (Hb) ≥ 80 g/L
Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
Platelet count (PLT) ≥ 75 × 10⁹/L
Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
Voluntary written informed consent obtained, with commitment to complete all treatment and follow-up visits.
Exclusion Criteria:
Target lesions previously treated with radiotherapy with a biologically effective dose (BED₃) ≥ 60 Gy (calculated with α/β = 3 Gy).
Target lesions deemed unsuitable for radiotherapy by the treating radiation oncologist (e.g., lesions invading t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From enrollment to the end of treatment (up to approximately 2 years)