Triple drug combo targets advanced liver cancer in new trial
NCT ID NCT07829926
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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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.
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