Tests vorolanib with everolimus against sunitinib in advanced kidney cancer
Compares vorolanib plus everolimus with sunitinib in adults with advanced kidney cancer after immunotherapy.
Key facts
- Who runs it
- Peking University Cancer Hospital & Institute
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- 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
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 116 people, planned
- Started
- 25 Sept 2025
- Expected to end
- 30 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Vorolanib Tablets+Everolimus
- Sunitinib
- Record updated
- 10 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced clear cell kidney cancer whose first treatment with a PD-1/PD-L1 immunotherapy, alone or with an anti-VEGFR TKI, has stopped working.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Advanced or metastatic clear cell renal cell carcinoma confirmed by pathology, with at least one measurable lesion (RECIST 1.1) that has not had radiation therapy.
- Earlier treatment
- Must have failed treatment with a single anti-PD-1/PD-L1 drug, or anti-PD-1/PD-L1 plus an anti-VEGFR TKI. Must not have had other systemic anticancer treatment for clear cell renal cell carcinoma.
Main reasons for not taking part
- Currently having anticancer therapy (local radiotherapy for bone metastases is the exception)
- Active infectious disease
- Major surgery within 4 weeks before enrolment
- Pregnant or breastfeeding women
- Severe lung disease, asthma or COPD with moderate or worse lung function
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Undergone major surgery within 4 weeks prior to enrollment
- Subjects with known hypersensitivity to similar drugs
- Subjects with active infectious diseases
- Any uncontrolled clinical condition
- 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
- Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment
- Pregnant or lactating women
- Any other factors deemed by the investigator to make the subject unsuitable for participation in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Peking University Cancer HospitalBeijing, ChinaContact: Sheng XinanNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Vorolanib Tablets+EverolimusTreatment being tested
- SunitinibExisting treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests vorolanib with everolimus against sunitinib in advanced kidney cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07165418, who can take part
- Record updated
- 10 September 2025