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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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).
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.
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGObjective Response Rate (ORR)
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
Local Control Rate
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
Disease Control Rate (DCR)
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
Progression-Free Survival (PFS)
Time frame: From first SABR to disease progression or death, whichever occurs first (up to approximately 4 years)
Overall Survival (OS)
Time frame: From first SABR to death from any cause (up to approximately 4 years)
Safety (Adverse Events)
Time frame: From first dose of study treatment to 30 days after last dose (up to approximately 2.5 years)
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