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SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma

NCT07744932 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Oligometastatic Clear Cell Renal Cell Carcinoma

Interventions

DRUG

axitinib plus toripalimab

Axitinib 5 mg administered orally twice daily continuously, combined with toripalimab 240 mg administered intravenously every 3 weeks for up to 35 cycles (approximately 2 years).

RADIATION

SABR

All participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions, delivering ≥7 Gy per fraction in 5 fractions, achieving a biologically equivalent dose (BED₃) ≥ 115 Gy based on α/β = 3 Gy. For lesions adjacent to organs at risk, partial-SABR is permitted. If SABR or partial-SABR is infeasible, moderately hypofractionated radiotherapy (MHFRT) with curative intent may be substituted at the discretion of the radiation oncologist.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744932 on ClinicalTrials.gov