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Triple drug combo targets advanced liver cancer in new trial

NCT ID NCT07829926

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing a drug combination for people with advanced hepatocellular carcinoma, a type of liver cancer that cannot be removed by surgery. Participants receive lenvatinib plus tislelizumab, and some also receive gefitinib. The trial compares how long people live without their cancer getting worse and tracks specific side effects. Everyone receives active treatment, and doctors know which drugs each person gets.

What this could mean

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

Active substance
lenvatinib plus tislelizumab, with or without gefitinib
What this could lead to
If adding gefitinib helps, it could offer a stronger first-line option for people with advanced liver cancer. It could also point to new combination strategies for hard-to-treat tumors.
What could go wrong
This is a mid-stage trial with 120 people, so results may not hold in larger groups. Combining three drugs can raise the risk of side effects, and the extra drug may add little benefit.

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 120 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 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: * Age 18 to 75 years, male or female. * Histologically or clinically/radiologically confirmed hepatocellular carcinoma. * Unresectable or advanced hepatocellular carcinoma requiring systemic therapy. * No prior systemic anticancer therapy for hepatocellular carcinoma. * At least one measurable lesion according to RECIST version 1.1. * Eastern Cooperative Oncology Group performance status of 0 to 1. * Child-Pugh class A liver function. * Life expectancy of at least 12 weeks. * Adequate hematologic, hepatic, renal, and coagulation function as defined in the protocol. * For participants with hepatitis B virus infection, antiviral therapy must be given according to local practice, and hepatitis B virus DNA must meet protocol-defined requirements. * Participants of childbearing potential must agree to use effective contraception during the study and for the protocol-defined period after the last dose of study treatment. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Prior systemic anticancer therapy for hepatocellular carcinoma. * Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-hepatocellular carcinoma histology. * Prior treatment with an epidermal growth factor receptor inhibitor. * Uncontrolled hypertension, clinically significant cardiovascular disease, or serious bleeding or thrombotic events within the protocol-defined period. * Active or high-risk gastrointestinal bleeding, untreated or inadequately treated esophageal or gastric varices, or clinically significant coagulation disorder. * History of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or active pneumonitis. * Active autoimmune disease or history of autoimmune disease requiring systemic treatment, except as allowed by the protocol. * Active uncontrolled infection, including uncontrolled hepatitis B virus infection or hepatitis C virus infection requiring treatment but not adequately controlled. * Known human immunodeficiency virus infection with uncontrolled disease, if applicable according to local regulations. * Clinically significant ascites, hepatic encephalopathy, or other evidence of hepatic decompensation. * Untreated or symptomatic central nervous system metastases. * Major surgery, locoregional therapy, radiotherapy, or other anticancer therapy within the protocol-defined washout period before randomization. * Inability to swallow oral medication or any condition that may significantly affect absorption of oral study drugs. * Known allergy or hypersensitivity to lenvatinib, tislelizumab, gefitinib, or any of their excipients. * Pregnancy or breastfeeding. * Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study or interfere with study treatment, safety evaluation, or protocol compliance.

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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

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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.