NCT07165418Not 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
A Multicenter, Randomized Controlled Study Comparing Vorolanib Tablets Plus Everolimus With Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed on Immunotherapy Monotherapy or in Combination With TKI
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Kidney cancer
- NCT number
- NCT07165418
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 116
- From 25 Sept 2025 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- Undergone major surgery within 4 weeks prior to enrollment;
Other illness
- Subjects with known hypersensitivity to similar drugs;
- Subjects with active infectious diseases;
- Any uncontrolled clinical condition;
- History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;
- Any condition affecting the subject's ability to swallow medication;
- Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment;
Other
- Pregnant or lactating women;
- Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.
Who the study is looking for
- 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;
- Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.