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SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma

ConditionOligometastatic Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • axitinib plus toripalimab

    Drug

    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).

  • SABR

    Radiation

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: SABR + Axitinib + ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
From enrollment to the end of treatment (up to approximately 2 years)

Secondary outcomes

1

Local Control Rate

Time frame
From enrollment to the end of treatment (up to approximately 2 years)
2

Disease Control Rate (DCR)

Time frame
From enrollment to the end of treatment (up to approximately 2 years)
3

Progression-Free Survival (PFS)

Time frame
From first SABR to disease progression or death, whichever occurs first (up to approximately 4 years)
4

Overall Survival (OS)

Time frame
From first SABR to death from any cause (up to approximately 4 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov
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