New hope for kidney cancer: drug combo targets tumors after immunotherapy fails
NCT ID NCT07165418
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 3 trial tests whether a combination of two drugs, vorolanib and everolimus, can help people with advanced kidney cancer whose disease has worsened after immunotherapy. About 116 participants will be randomly assigned to receive either the combo or the standard drug sunitinib. The goal is to see if the combo can delay cancer growth and improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vorolanib tablets plus everolimus
- What this could lead to
- If successful, this combination could offer a new second-line treatment option for advanced kidney cancer patients who have already tried immunotherapy.
- What could go wrong
- This is a phase 3 trial, but it's still early to know if the combination works better than existing options. Side effects from the drugs may occur, and the study is relatively small (116 patients).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pathologically confirmed renal clear cell carcinoma (histological or cytological); 2. 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; 3. Age 18 to 80 years; 4. Estimated survival exceeding 12 weeks; 5. KPS score ≥70; 6. At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy; 7. Adequate organ function levels; 8. 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; 9. Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures. Exclusion Criteria: 1. Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma; 2. Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma; 3. Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases); 4. Subjects with known hypersensitivity to similar drugs; 5. Subjects with active infectious diseases; 6. Any uncontrolled clinical condition; 7. Undergone major surgery within 4 weeks prior to enrollment; 8. History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol; 9. Any condition affecting the subject's ability to swallow medication; 10. Pregnant or lactating women; 11. Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment; 12. Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can fasting two days a week slow kidney cancer? a new trial tests the idea
- Cell therapy combo aims to boost kidney cancer treatment
- First-in-Class cancer drug targets Hard-to-Treat tumors
- Immunotherapy after kidney cancer surgery: can a blood test predict who stays Cancer-Free?
- Engineered immune cells take on kidney cancer in first human test