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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
. Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
. Subjects with known hypersensitivity to similar drugs;
. Subjects with active infectious diseases;
. Any uncontrolled clinical condition;
. Undergone major surgery within 4 weeks prior to enrollment;
. History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;