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Triple therapy aims to shrink liver tumors before surgery

NCT ID NCT07014150

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether giving a combination of two immunotherapy drugs (iparomlimab and tuvonralimab) plus a targeted therapy (lenvatinib) before surgery can improve outcomes for people with liver cancer at high risk of recurrence. About 33 participants will receive the drugs for 9 weeks, then have surgery. Researchers will measure how many tumors shrink or disappear and track safety and long-term survival.

What this could mean

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

Active substance
iparomlimab, tuvonralimab, and lenvatinib
What this could lead to
If successful, this combination could shrink liver tumors before surgery and lower the chance of cancer coming back, offering a better treatment path for high-risk patients.
What could go wrong
This is a small, early-phase trial with only 33 participants, so results may not apply broadly. The drug combination can cause side effects like fatigue, high blood pressure, or immune-related reactions.

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 33 people

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

Started

Jun 2025

Expected to finish

May 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: * The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up * Be at least 18 years old at the time of signing the informed consent form, with no gender restrictions. * Hepatocellular carcinoma diagnosed by histology or imaging * At least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm) * No systematic treatment has been received before * CNLC:Ib to IIIa * There is at least one of the following high-risk factors for postoperative recurrence: AFP\>400ng/ml; Single tumor \>5cm; The number of tumors is greater than 3 or any one of them is greater than 3cm; There are vascular tumor thrombus or tumors adjacent to large blood vessels, etc. * The ECOG score was 0-1 within one week before enrollment * Hematology and organ functions are adequate * Fertile women: Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during the treatment period and for at least 6 months after the last administration Exclusion Criteria: * Have received any systemic treatment * ECOG score \>1 * Definite extrahepatic metastasis * Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women * Those who are known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components (or any excipients) * Previous or existing grade 3 or above digestive tract fistulas or non-digestive tract fistulas (such as skin) as defined by CTCAE 5.0 criteria * Major surgical operations (except biopsy) have been performed within 4 weeks before the first study of drug treatment or the surgical incision has not fully healed * Cardiovascular and cerebrovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction and severe/unstable angina pectoris that occurred within 6 months before enrollment * Insufficiency of liver and kidney functions, such as jaundice, ascites, and/or bilirubin \>3×ULN, creatinine ratio \>3.5g/24 hours, etc * Persistent infection of grade \>2 (CTCAE 5.0) * A history of thromboembolism (including stroke and/or transient ischemic attack) within the past 6 months * Hypertension that has not been well controlled after antihypertensive drug treatment (systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg) * An active autoimmune disease or a history of autoimmune diseases in the past two years * Active central nervous system (CNS) metastases and/or cancerous meningitis * Be ready or have received organ or allogeneic bone marrow transplants before * Known history of active tuberculosis (Mycobacterium tuberculosis) * A history of gastrointestinal bleeding within the past 6 months or a clear tendency towards gastrointestinal bleeding * History of human immunodeficiency virus (HIV) infection * Positive for active hepatitis B or hepatitis C and has not received regular treatment. During the screening period, HBV DNA≥2000 IU/ml (or ≥104 copy number /ml), entecavir must be used to reduce it to \<2000 IU/ml (or \< 104 copy number /ml) before enrollment * There is drug abuse; Or any medical, psychological or social conditions that may affect the research, cause unstable patient compliance, or even endanger patient safety * Unresolved toxicity of grade \> 1 due to any previous treatment/procedure (CTCAE 5.0, excluding alopecia, anemia, and hypothyroidism). * Patients with objective evidence of severe lung function impairment in the past or at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia * Received treatment with potent CYP3A4 inhibitors within 7 days before participating in the study * Accompanied by other malignant tumors, but having had other untreated malignant tumors in the past (within 5 years) or simultaneously, for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, treated superficial bladder cancer and prostate adenocarcinoma that has undergone surgical treatment and whose PSA tumor markers are within the normal range. * After a comprehensive assessment of the patient's condition by the researchers, it was determined that they were not suitable to participate in this research * Participate in another clinical 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

  • Chinese Academy of Medical Sciences,Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

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