New combo therapy aims to stop liver cancer spread in its tracks
NCT ID NCT07537946
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding targeted radiation or other local treatments to standard drug therapy can help people with liver cancer that has spread to a few spots outside the liver. All 400 participants first receive a combination of the immunotherapy sintilimab and the targeted drug lenvatinib. Those whose cancer is controlled are then randomly assigned to either continue the drugs alone or also receive local treatments to destroy remaining tumors. The main goal is to see if the combined approach improves overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab and lenvatinib
- What this could lead to
- If successful, this could offer a new treatment strategy to extend survival for people with liver cancer that has spread to a few spots outside the liver.
- What could go wrong
- This is an early-stage trial with no results yet. The added local therapy may not improve survival and could cause more side effects. The combination of drugs already has known risks like high blood pressure and liver problems.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
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 * Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards * Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs * At least 1 measurable lesion according to RECIST version 1.1 * No prior systemic therapy for advanced or metastatic hepatocellular carcinoma * ECOG performance status 0 to 1 * Child-Pugh class A or stable Child-Pugh B7 * Adequate hematologic, hepatic, renal, and coagulation function according to protocol * Baseline center multidisciplinary team assessment indicating potential feasibility for complete consolidative intent if disease control is achieved after induction * Written informed consent and willingness to comply with treatment, follow-up, and protocol-required assessments Exclusion Criteria: * More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs * Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases * Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction * Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment * Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC * Active autoimmune disease requiring systemic immunosuppression * Active severe infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or uncontrolled hepatitis B without appropriate antiviral therapy * Gastrointestinal bleeding within the previous 6 months, or untreated or uncontrolled high-risk gastroesophageal varices * Uncontrolled hypertension, recent major thrombotic event, myocardial infarction, unstable angina, or stroke * Active interstitial lung disease or noninfectious pneumonitis requiring systemic treatment * Severe proteinuria or renal dysfunction considered unsuitable for lenvatinib treatment * Pregnancy or breastfeeding * Any condition that, in the investigator's judgment, would make participation unsafe or compromise 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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Saline barrier lets heat target liver tumors near the diaphragm
- Can a new PET tracer spot liver cancer more clearly?
- Can a smart drug starve liver tumors without harming healthy tissue?
- Liver size may hold key to immunotherapy response
- Can a new model forecast liver cancer in hepatitis b?