Recruiting soon

Vorolanib and Everolimus for Advanced Renal Cell Carcinoma After Immunotherapy

What is being tested

Vorolanib Tablets+Everolimus

+ Sunitinib

Drug

Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

From 18 to 80 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorPeking University Cancer Hospital & Institute

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 25, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding better treatment options for patients with advanced kidney cancer, specifically renal cell carcinoma, who have not responded to initial treatments. The goal is to see if a combination of two drugs, vorolanib and everolimus, can be more effective and safer than the standard treatment with sunitinib. This research is important because it aims to improve treatment options for patients who have limited choices after their cancer has progressed despite initial therapies. Participants in this study are divided into two groups; one group receives vorolanib and everolimus, while the other group receives sunitinib. Vorolanib and everolimus are taken as tablets, and the treatment continues until the cancer shows signs of progressing. The study evaluates how well these treatments work by monitoring disease progression and checking for any side effects, helping determine if the new combination can offer better outcomes for patients.

Official TitleA 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

Principal SponsorPeking University Cancer Hospital & Institute

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaCarcinoma, Renal CellFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate

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;

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12 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking University Cancer Hospital

Beijing, ChinaOpen Peking University Cancer Hospital in Google Maps

Recruiting soonOne Study Center