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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 | Clinical Trials | Clareo Health

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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

NCT07165418•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Pathologically confirmed renal clear cell carcinoma (histological or cytological);
•2. 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;
•3. Age 18 to 80 years;
•4. Estimated survival exceeding 12 weeks;
•5. KPS score ≥70;
•6. At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy;
•7. Adequate organ function levels;
•8. 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;
•9. Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures.

Exclusion Criteria

•1. Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
•2. Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
•3. Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
•4. Subjects with known hypersensitivity to similar drugs;
•5. Subjects with active infectious diseases;
•6. Any uncontrolled clinical condition;
•7. Undergone major surgery within 4 weeks prior to enrollment;
•8. History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;
•9. Any condition affecting the subject's ability to swallow medication;
•10. Pregnant or lactating women;
+2 more criteria

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 25, 2025

Primary Completion Date

December 30, 2028

Completion Date

December 30, 2029

Last Updated

September 10, 2025

Enrollment

116

ESTIMATED participants

Conditions

Renal Cell Carcinoma (RCC)

Interventions

Vorolanib Tablets+Everolimus

DRUG

Sunitinib

DRUG

PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

NCT07175480

Renal Cell Carcinoma (RCC)Metastatic Renal Cell Carcinoma (mRCC)

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RECRUITINGPHASE2

Ablative Radioembolization of Renal Cell Carcinoma Trial

NCT06642220

Renal Cell Carcinoma (RCC)Radioembolization

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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