A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Adva… (NCT07165418) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI
China116 participantsStarted 2025-09-25
Plain-language summary
This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Pathologically confirmed renal clear cell carcinoma (histological or cytological);
✓. Subjects who have failed prior treatment with a single anti-PD-1/PD-L1 agent or a combination of anti-PD-1/PD-L1 and anti-VEGFR TKI;
✓. Age 18 to 80 years;
✓. Estimated survival exceeding 12 weeks;
✓. KPS score ≥70;
✓. At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy;
✓. Adequate organ function levels;
✓. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; all enrolled subjects (male or female) must use effective barrier contraception throughout treatment and for 4 weeks post-treatment;
Exclusion criteria
✕. Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
What they're measuring
1
Progression Free Survival（PFS）
Timeframe: The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.
Trial details
NCT IDNCT07165418
SponsorPeking University Cancer Hospital & Institute