Can a triple drug attack stop liver cancer from coming back?

NCT ID NCT07790419

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether combining three treatment approaches can reduce the chance of liver cancer returning after surgery. People who had their liver cancer completely removed but showed signs of microvascular invasion, a risk factor for recurrence, will receive chemotherapy directly into the liver, a daily targeted therapy pill, and an immunotherapy infusion. The study tracks how long participants stay free of cancer and overall survival. The goal is to see if this aggressive combination offers better protection than standard care.

What this could mean

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

Active substance
A combination of hepatic artery infusion chemotherapy (oxaliplatin and 5-fluorouracil), targeted therapy (donafenib, lenvatinib, or apatinib), and a PD-1 inhibitor (sintilimab, camrelizumab, or tislelizumab)
What this could lead to
If it works, this combination could help prevent liver cancer from returning after surgery, potentially improving long-term survival for people with microvascular invasion.
What could go wrong
This is a small, single-arm trial with no comparison group, so results may not be definitive. The combination of chemotherapy, targeted drugs, and immunotherapy can cause significant side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 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. Age 18-80 years, male or female; 2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins; 3. Microvascular invasion (MVI) grade ≥ 1 4. No other history of tumors and no preoperative anticancer treatment. 5. ECOG: 0-1; 6. Baseline blood count tests and blood biochemistry must meet the following criteria: Hemoglobin ≥80 g/L; Absolute neutrophil count ≥1.5×109/L; Platelet count ≥50×109/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN); Total bilirubin ≤3 times ULN; Serum creatinine ≤1.5 times ULN; Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s; International normalized ratio (INR) ≤2.3 7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends; 8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up. Exclusion Criteria: * 1\. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included); 2\. Pregnancy or lactation; 3\. Over 80 years old; 4\. Prior systemic chemotherapy or radiotherapy; 5\. Concomitant malignant pleural effusion or ascites; 6\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 7\. Concomitant infection requiring anti-infective treatment; 8\. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease; 9\. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix; 10\. Uncorrectable coagulation disorders; 11\. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension; 12\. History of myocardial infarction within 12 months, or cardiac function class III or IV; 13\. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases; 14\. Individuals deemed unsuitable for inclusion by the investigator.

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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

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

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