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New combo offers hope for kidney cancer patients who stopped responding to immunotherapy

NCT ID NCT06035224

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, cadonilimab and lenvatinib, in 28 adults with advanced clear cell kidney cancer that worsened after initial immunotherapy. The goal is to see if the combo can shrink tumors or slow disease progression. Participants receive treatment until their cancer progresses or side effects become too severe.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Oct 2026

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.

Criteria: Inclusion Criteria: 1. Written informed consent provided prior to study procedures. 2. Age ≥18 and ≤80 years at the time of consent. 3. Histologically or cytologically confirmed renal cell carcinoma with clear cell component. 4. Unresectable locally advanced or metastatic disease. 5. Radiographic disease progression during or after prior first-line immunotherapy-based combination therapy for advanced RCC. 6. At least one measurable lesion according to RECIST v1.1. 7. ECOG performance status of 0 or 1. 8. Estimated life expectancy of at least 3 months. 9. Adequate organ function, including hematologic, renal, hepatic, and coagulation parameters, as defined in the protocol. Exclusion Criteria: 1. History of hypersensitivity to monoclonal antibodies or any component of cadonilimab or lenvatinib. 2. Known additional malignancy that is progressing or has required active treatment. Exceptions include adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ. 3. Prior treatment with dual immune checkpoint blockade, defined as anti-PD-1/PD-L1 combined with anti-CTLA-4 therapy. 4. Uncontrolled clinically significant cardiovascular disease or symptoms. 5. Diagnosis of immunodeficiency or receipt of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to first dose. 6. Active autoimmune disease or history of autoimmune disease that may worsen with immunostimulatory therapy. Subjects with type 1 diabetes mellitus, vitiligo, psoriasis, or hypo-/hyperthyroidism not requiring immunosuppressive treatment are eligible. 7. History of non-infectious pneumonitis requiring steroids or current pneumonitis/interstitial lung disease. 8. Active tuberculosis or active syphilitic infection. 9. Known history of human immunodeficiency virus (HIV) infection. 10. Active hepatitis B infection (HBsAg positive with HBV DNA \>500 IU/mL) or active hepatitis C infection (detectable HCV RNA). 11. Clinically significant toxicities from prior anticancer therapy not recovered to Grade ≤1 (except alopecia or stable endocrinopathies). 12. Active bleeding disorder or history of clinically significant bleeding episodes. 13. Drug abuse, psychiatric illness, or medical/social conditions that may interfere with study participation or evaluation of results. 14. Pregnant or breastfeeding women, or participants planning conception during the study treatment period. \-

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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.

Contacts and locations

Locations

  • Shanghai Renji Hospital

    Shanghai, Shanghai Municipality, 200123, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.