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

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

Overview

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.

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.

Primary outcome measures

• Progression Free Survival（PFS） [Time frame: The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.]

Secondary outcome measures (5)

• Overall Survival（OS） [Time frame: The duration of treatment is determined from the start date to the date of death, or the last visit date serves.Estimate up to 3 years]
• Objective Response Rate（ORR） [Time frame: From the start of receiving the treatment regimen in this study until the subject's disease progression and subsequent withdrawal from the study.Estimate up to 2 years]
• Disease Control Rate（DCR） [Time frame: Estimate up to 2 years]
• Duration of Relief (DOR) [Time frame: The time from the first assessment of tumor response as CR or PR (whichever occurs first) to the first assessment of PD or death from any cause (whichever occurs first).Estimate up to 2 years.]
• Adverse Events (AE) [Time frame: about 2 years]

Eligibility criteria

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;
• 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 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University Cancer Hospital — Beijing

Identifiers

NCT: NCT07165418 · 2025YJZ61

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗