SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase II study, patients with oligometastatic clear cell renal cell carcinoma will receive SABR to all metastatic sites in five sessions while also taking axitinib daily and receiving toripalimab every three weeks for up to two years. The trial aims to determine the objective response rate, progression-free survival, overall survival, and safety. Imaging, lab tests, and quality-of-life assessments will monitor response and tolerability. Approximately 48 participants are planned for enrollment, each followed closely to gauge benefits and risks of the combination therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• the Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Study coordinator: Linlin Xiao, Dr
• Email: drxiaolinlin@163.com
• Phone: 18533167355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.