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NOT YET RECRUITING
NCT07165418
PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-09-25

Completion Date

2029-12-30

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

Vorolanib Tablets+Everolimus

Subjects received oral vorinib 200 mg once daily (QD) plus everolimus 5 mg once daily (QD), administered within 30 minutes after breakfast daily. Treatment cycles lasted 28 days and continued until disease progression.

DRUG

Sunitinib

Subjects received oral sunitinib 50 mg once daily (QD) in a 4-week on, 2-week off regimen or a 2-week on, 1-week off regimen until disease progression.

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China