Can a triple strike of radiation, targeted therapy, and immunotherapy tame metastatic kidney cancer?
NCT ID NCT07744932
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining precise, high-dose radiation (SABR) with the targeted drug axitinib and the immunotherapy toripalimab can shrink or control tumors in people with oligometastatic clear cell renal cell carcinoma—kidney cancer that has spread to five or fewer sites. About 48 participants will receive SABR to all metastatic lesions, along with daily axitinib pills and toripalimab infusions every three weeks for up to two years. The main goal is to measure how many patients see their tumors shrink or disappear, while also tracking survival, side effects, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic ablative radiotherapy (SABR) combined with axitinib and toripalimab
- What this could lead to
- If successful, this combination could offer a more effective way to control kidney cancer that has spread to a few sites, potentially improving response rates and survival.
- What could go wrong
- This is an early-phase, single-center study with a small number of participants. The combination may cause significant side effects, and results may not generalize to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the Fourth Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050011, China
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