New four-drug cocktail targets tough liver cancers with promising early trial
NCT ID NCT07350070
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of four treatments for people with liver cancer that cannot be removed by surgery and who also have high blood pressure in the liver (portal hypertension). The goal is to see if adding a blood-pressure drug (carvedilol) to standard cancer therapies (TACE, immunotherapy, and a targeted drug) can improve tumor shrinkage and safety. About 78 adults aged 18-75 with newly diagnosed liver cancer will take part. The approach aims to control the disease while protecting the liver.
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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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 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: * Aged 18-75 years. * At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (tumor lesion long axis ≥10 mm on CT scan). * Newly diagnosed hepatocellular carcinoma without any prior treatment for HCC. * Child-Pugh liver function score ≤ 7. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. * Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain). * Compensated cirrhosis with clinically significant portal hypertension (meeting any one of the following criteria): 1. Imaging evidence (ultrasound, CT, or MRI) of portosystemic collateral circulation. 2. Endoscopic evidence of esophageal or gastric varices. 3. Liver stiffness measurement (LSM) \>25 kPa; or LSM 20-25 kPa with platelet count \<150×10⁹/L; or LSM 15-20 kPa with platelet count \<110×10⁹/L. Exclusion Criteria: * Decompensated cirrhosis. * Concurrent other malignancies or recurrent HCC. * Any active, known, or suspected autoimmune disease. * History of allergy to any component of PD-1 inhibitors, lenvatinib, or carvedilol. * Severe concurrent medical conditions, including asthma, significant cardiac conduction block, and sinus bradycardia. * Known human immunodeficiency virus (HIV) infection; or active hepatitis (e.g., hepatitis B/C virus infection). * Presence of tumor thrombus in the inferior vena cava, hepatic vein, or main portal vein.
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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
7 sites. 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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Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Department of Hepatobiliary and Pancreatic Oncology
Fuzhou, Fujian, China
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Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
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Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
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Hubei Province Tahe Hospital
Taihe, Hubei, China
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Organ Transplant Department,Qilu Hospital, Cheeloo College of Medicine, Shandong University,
Jinan, Shandong, 250012, China
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Qingdao University Affiliated Hospital
Qingdao, Shandong, China
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Shandong First Medical University Affiliated Provincial Hospital
Jinan, Shandong, China
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Other studies related to the condition(s) this trial covers.
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- Gut bacteria in a capsule: a new attempt to calm a brain complication of cirrhosis
- Ultrasound may replace invasive test for dangerous liver complication
- Can a digital platform catch liver cancer sooner?
- Can a Two-Drug combo keep cirrhosis patients out of the hospital?