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New immunotherapy combo aims to fight advanced kidney cancer

NCT ID NCT07159191

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two drugs—envafolimab (an immunotherapy injection) and axitinib (a targeted therapy pill)—as a first treatment for people with advanced kidney cancer that has spread or cannot be removed. About 30 participants will receive the treatment for up to 2 years. Researchers will measure how well the drugs shrink tumors and control the cancer, while closely monitoring side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Envafolimab (immunotherapy injection) and Axitinib (targeted therapy pill)
What this could lead to
If successful, this combination could offer a new first-line treatment option for advanced kidney cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is a small, early-phase (Phase 2) study with only 30 participants and no comparison group. The treatment may cause side effects like immune reactions or high blood pressure, and may not work for everyone.

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

About 30 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

Jul 2027

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 75 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\. Sign an informed consent form in writing; 2. Age between 18 and 75 years old; 3. Unresectable or metastatic clear cell renal cell carcinoma; 4. No prior systemic anti-tumor treatment; 5. Measurable disease according to RECIST v1.1; 6. ECOG performance status: 0 to 1; 7. Adequate organ and bone marrow function: 1. Complete blood count: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L, Platelet (PLT) count ≥ 70 × 10\^9/L, Hemoglobin (HGB) ≥ 90 g/L; 2. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤ 3 × ULN; Serum Albumin ≥ 28 g/L; Alkaline Phosphatase (ALP) ≤ 5 × ULN; subjects who meet the above criteria after routine liver protection treatment and have been stable for at least one week after assessment by the researcher can be enrolled; 3. Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (using the standard Cockcroft-Gault formula); 4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 / Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN; if the subject is undergoing anticoagulant therapy, as long as PT and INR are within the range specified for the anticoagulant medication, they are eligible. 8\. Estimated life expectancy ≥ 6 months; 9. Subjects voluntarily participate in this study and have good compliance. Exclusion Criteria: * 1\. A history of or concurrent with other malignant tumors; 2. Patients who have previously received systemic anti-tumor treatment; 3. Known allergies to macromolecular protein preparations or components of the study medication in the subject's history; 4. Active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) have occurred within 2 years prior to the first dose of the study medication. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment; 5. Receiving systemic corticosteroid treatment (excluding nasal, inhalation, or other local routes of administration) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study medication; Note: The use of physiological doses of corticosteroids (equivalent to ≤50 mg/day of hydrocortisone or equivalent) is permitted; 6. The subject has been using traditional Chinese medicine or other immunomodulators within 2 weeks prior to enrollment; 7. Symptomatic ascites or pleural effusion that cannot be controlled with medication and requires therapeutic puncture or drainage; 8. Uncontrolled cardiac clinical symptoms or diseases, such as: 1. Heart failure at NYHA class 2 or above; 2. Unstable angina; 3. Myocardial infarction within the past year; 4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Known history of abuse of psychiatric drugs, alcoholism, or drug addiction in the subject; 10. Pregnant or nursing women; 11. Men or women of childbearing potential (referring to men or women who have not undergone sterilization surgery, as well as women who have not reached menopause) must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) during the trial and continue to use contraceptives for 6 months after the last dose; 12. The investigator deems that the subject should be excluded from this study, for example, if the investigator judges that the subject has other factors that may force the study to be terminated prematurely, such as other serious diseases (including psychiatric diseases) requiring concurrent treatment, severe laboratory test abnormalities, or family or social factors that may affect the subject's safety or the collection of data and samples.

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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 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 ↗

  2. A doctor treating you

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More trials for these conditions

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