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

NCT07165418 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025YJZ61
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Cell Carcinoma (RCC)

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival（PFS）

  The time from study entry to the first disease progression (PD) or death from any cause, as assessed by the investigator.

  The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.

Secondary Outcomes (5)

• Overall Survival（OS）

  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）

  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）

  Estimate up to 2 years

• Duration of Relief (DOR)

  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)

  about 2 years

Study Arms (2)

Vorolanib Tablets+Everolimus

EXPERIMENTAL

Drug: Vorolanib Tablets+Everolimus

Sunitinib

ACTIVE COMPARATOR

Drug: Sunitinib

Interventions

Vorolanib Tablets+Everolimus DRUG

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.

Vorolanib Tablets+Everolimus

Sunitinib DRUG

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.

Sunitinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Peking University Cancer Hospital

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-08

Locations

CN (1)