Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Renal Cell Carcinoma (RCC)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 mon...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Any condition affecting the subject's ability to swallow medication;
- Pregnant or lactating women;
- Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment;
- Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT07165418
Start Date
September 25 2025
End Date
December 30 2029
Last Update
September 10 2025
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China