Renal Cell Carcinoma (RCC)Phase 3NCT07165418
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
A Phase 3 study testing Vorolanib Tablets+Everolimus and Sunitinib in people with Renal Cell Carcinoma (RCC), run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Vorolanib Tablets+Everolimus and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 30 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality
Sheng Xinan, 010-88196348, doctor_sheng@126.com
About this study
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
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)
- Being tested
- Vorolanib Tablets+Everolimus, Sunitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorolanib Tablets+EverolimusDrug
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.
SunitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vorolanib Tablets+Everolimus | Experimental | Not described Receives: Drug: Vorolanib Tablets+Everolimus |
| Sunitinib | Active comparator | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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, regardless of the cause of death. For patients still alive at the time of final analysis, the last visit date serves as both the observation endpoint and the censoring date.
Measured: 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）
The percentage of subjects achieving a best response of complete remission (CR) or partial remission (PR) from the start of the study treatment regimen until disease progression or withdrawal from the study, relative to the total number of subjects in the analysis set. Assessed using RECIST 1.1 criteria.
Measured: 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）
The proportion of subjects achieving complete remission (CR), partial remission (PR), and stable disease (SD) among all subjects.
Measured: 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).
Measured: 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)
Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start25 Sep 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun GUO, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165418
- Sponsor's protocol ID
- 2025YJZ61
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07165418
- Acronym / sponsor ID
- 2025YJZ61
- Conditions
- Renal Cell Carcinoma (RCC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vorolanib Tablets+Everolimus | Experimental | Drug: Vorolanib Tablets+Everolimus |
| Sunitinib | Active comparator | Drug: Sunitinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vorolanib Tablets+EverolimusSubjects 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 | Vorolanib Tablets+Everolimus |
| SunitinibSubjects 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. | Drug | Sunitinib |
Primary outcome
Progression Free Survival（PFS）
Time frame: The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.
The time from study entry to the first disease progression (PD) or death from any cause, as assessed by the investigator.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vorolanib Tablets+Everolimus and Sunitinib in people with Renal Cell Carcinoma (RCC), run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival（PFS） (time frame: The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.