Radiation with axitinib and toripalimab for kidney cancer spread to a few sites
Tests radiation with two cancer drugs in adults with kidney cancer spread to few sites.
Plain-language title generated from the registry record
Registry title: SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma
Key facts
- Where
- Shijiazhuang, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with clear cell kidney cancer that has spread to 5 or fewer places. It tests radiation (SABR) with axitinib and toripalimab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Clear cell renal cell carcinoma with distant spread to 5 or fewer measurable lesions, all treatable with radiation meant to remove all of the disease.
- Earlier treatment
- Must have had definitive treatment of the main kidney tumor (surgery, stereotactic radiotherapy or ablation). Either no earlier drug treatment for the spread, or only an earlier TKI drug with 5 or fewer lesions growing.
Main reasons for not taking part
- Target lesions already treated with radiation at a biologically effective dose of 60 Gy or more
- Lesions the radiation doctor judges unsafe to irradiate, for example invading the gut or bronchus
- Uncontrolled malignant fluid in the chest or belly
- Another cancer that is not cured
- Pregnancy, breastfeeding or planned pregnancy during the study
Read by machine on 13 November 2026.
Where in China
- The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Fengpeng WuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hebei Medical University Fourth Hospital
- Trial code
- NCT07744932
- Record updated
- 4 August 2026
- Original description
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).Read full original descriptionShow less
A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma
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.
Inclusion: 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: 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 the gastrointestinal tract or penetrating the bronchus); Uncontrolled malignant pleural effusion or ascites; Presence of other uncured malignancies; History of severe psychiatric illness interfering with understanding of informed consent or compliance with study procedures; Severe cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, uncontrolled arrhythmia, or myocardial infarction within the past 6 months; Any other serious medical condition that, in the investigator's judgment, may pose significant risk or interfere with radiotherapy; Pregnancy, breastfeeding, or planned pregnancy during the study period; Any other reason determined by the investigator that makes the participant unsuitable for study participation.