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New hope for kidney cancer: drug combo targets tumors after immunotherapy fails

NCT ID NCT07165418

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, China

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