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New combo therapy aims to slash liver cancer recurrence after surgery

NCT ID NCT07487662

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether combining local tumor treatments (TACE or ablation) with immunotherapy drugs (sintilimab and ipilimumab) before surgery can lower the chance of liver cancer coming back. It involves 105 adults with resectable liver cancer at intermediate-to-high risk of recurrence. The goal is to find a more effective pre-surgery regimen than surgery alone.

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 105 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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\) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion; 3\) No prior tumor-related treatment received; 4\) At least one measurable target lesion according to the RECIST 1.1 criteria; 5\) ECOG PS score of 0-1; 6\) Liver function classification: Child-Pugh Class A; 7\) Estimated survival time ≥ 12 weeks; 8\) Hematological, liver, and renal functions meet the following criteria: 1. Hemoglobin concentration ≥ 90 g/L; 2. Neutrophil count ≥ 1.5 × 10⁹/L; 3. Platelet count ≥ 75 × 10⁹/L; 4. Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal); 5. AST and ALT \< 5 × ULN; ALP \< 4 × ULN; 6. Creatinine ≤ 1.5 × ULN; 7. INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN; 8. Serum albumin concentration ≥ 30 g/L; 9\) Women of childbearing age must be excluded from pregnancy; 10\) For patients with other concurrent malignant tumors, MDT discussion must confirm that the history and treatment history of other tumors will not interfere with the efficacy and safety evaluation of this study protocol; 11\) Ability to understand and sign the informed consent form. Exclusion Criteria: * 1\) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis; 3\) History of other complex surgeries within 6 weeks; 4\) Prior history of organ transplantation; Currently receiving treatment in other clinical trials; 5\) Prior history of autoimmune diseases, inflammatory disorders (such as inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome (granulomatosis with polyangiitis, rheumatoid arthritis, etc.), except for the following cases: vitiligo or alopecia areata, hypothyroidism with stable condition after drug replacement therapy, chronic skin diseases that do not require systemic treatment, and celiac disease controllable by diet alone; 6\) Prior history of allergy to anti-PD1 drugs or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies; 7\) Uncontrollable intermittent recurrent diseases, including but not limited to: persistent infections (including tuberculosis), hypertension uncontrollable by drugs (\> 140/90 mmHg), interstitial lung disease, severe chronic gastrointestinal diseases complicated with diarrhea, mental illness or social disorders that cannot comply with clinical research requirements, factors with high risk of side effects, and inability to sign the informed consent form; 8\) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration; 9\) Untreated active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 5000 copies/mL (1000 IU/mL) or higher than the lower limit of detection, whichever is higher); for subjects with hepatitis B, anti-hepatitis B virus treatment is required during the study treatment; active hepatitis C subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 10\) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year; 11\) Primary immunodeficiency disease; 12\) Prior positive HIV test or acquired immunodeficiency syndrome (AIDS); 13\) Use of immunosuppressive drugs within 14 days before the start of study treatment. The following situations are exempt: 1. Intranasal, inhaled, topically used steroids or local steroid injections; 2. Systemic application of corticosteroids not exceeding the physiological dose (e.g., 10 mg/day prednisone or its equivalent); 3. Steroid application for the treatment of allergic reactions; 14\) Vaccination with live-attenuated vaccines within 30 days before the start of study treatment. Note: Live-attenuated vaccines should also be avoided during the study treatment and within 30 days after the end of treatment; 15\) Receipt of systemic immunostimulant treatment within the prior 4 weeks; 16\) Prior history of severe systemic diseases, including: myocardial infarction or unstable angina pectoris, hypertensive crisis or hypertensive encephalopathy, congestive heart failure of NYHA Class II or above, unstable symptomatic arrhythmia requiring drug intervention, severe vascular disease or symptomatic peripheral vascular disease, occurring within 12 months before the start of study treatment; 17\) History of coagulative, hemorrhagic or thrombotic diseases within 12 months before the start of study treatment; 18\) Severe, irreversible trauma, ulcers or fractures; 19\) Pregnant or lactating women, or subjects planning to have children during the trial period; 20\) Dependent on parenteral nutrition to maintain life; 21\) Other acute or chronic diseases, mental and psychological diseases, etc., which are not suitable for participating in this study, as judged by the researcher.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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