Combined treatment for liver cancer that cannot be removed, with cirrhosis and portal hypertension
Tests TACE with tislelizumab, lenvatinib and carvedilol in adults with liver cancer and cirrhosis.
Plain-language title generated from the registry record
Registry title: TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension
Key facts
- Where
- Fuzhou, Jinan, Nanning, Qingdao, Taihe, and Wuhan, ChinaSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with newly diagnosed liver cancer (HCC) that cannot be removed by surgery. They must also have compensated cirrhosis with clinically significant portal hypertension.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed hepatocellular carcinoma (HCC) that cannot be removed by surgery. It must have at least one lesion measurable on CT (long axis 10 mm or more). Compensated cirrhosis with clinically significant portal hypertension. Child-Pugh liver function score of 7 or less. ECOG performance status 0-1.
- Earlier treatment
- No earlier treatment for HCC.
- Biomarker or test result
- Clinically significant portal hypertension shown by at least one of these: collateral blood vessels on imaging, varices seen at endoscopy, or high liver stiffness (LSM >25 kPa; or LSM 20-25 kPa with platelets <150×10⁹/L; or LSM 15-20 kPa with platelets <110×10⁹/L).
Main reasons for not taking part
- Decompensated cirrhosis
- Other cancers, or HCC that has come back
- Active, known or suspected autoimmune disease
- Known HIV infection, or active hepatitis such as hepatitis B or C
- Tumor clot in the inferior vena cava, hepatic vein or main portal vein
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07350070, who can take part
Where in China
- Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Department of Hepatobiliary and Pancreatic OncologyFuzhou, ChinaContact: Hui ZhangNo longer taking part
- Organ Transplant Department,Qilu Hospital, Cheeloo College of Medicine, Shandong University,Jinan, ChinaContact: Enyu LiuNo longer taking part
- Shandong First Medical University Affiliated Provincial HospitalJinan, ChinaContact: Hong ChangNo longer taking part
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Guangdou YuanNo longer taking part
- Qingdao University Affiliated HospitalQingdao, ChinaContact: Jingyu CaoNo longer taking part
- Hubei Province Tahe HospitalTaihe, ChinaContact: Huawu ZhouNo longer taking part
- Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Wanguang ZhangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tongji Hospital
- Trial code
- NCT07350070
- Record updated
- 20 January 2026
- Original description
In China, the majority of hepatocellular carcinoma (HCC) cases stem from chronic hepatitis B virus (HBV) infection and subsequent cirrhosis, with patients often presenting at the decompensated stage complicated by clinically significant portal hypertension (CSPH). CSPH not only limits treatment options and worsens prognosis but also leads to the frequent exclusion of such patients from pivotal clinical trials, resulting in a lack of high-level evidence for their management. Carvedilol, a non-selective beta-blocker, is a first-line therapy for portal hypertension. Emerging evidence suggests that this drug class may also modulate the tumor microenvironment and enhance the efficacy of immune checkpoint inhibitors.Read full original descriptionShow less
TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for the Treatment of Unresectable Hepatocellular Carcinoma With Cirrhotic Portal Hypertension: A Multicenter, Simon Two-Stage, Single-Arm Study
In China, the majority of hepatocellular carcinoma (HCC) cases stem from chronic hepatitis B virus (HBV) infection and subsequent cirrhosis, with patients often presenting at the decompensated stage complicated by clinically significant portal hypertension (CSPH). CSPH not only limits treatment options and worsens prognosis but also leads to the frequent exclusion of such patients from pivotal clinical trials, resulting in a lack of high-level evidence for their management. Carvedilol, a non-selective beta-blocker, is a first-line therapy for portal hypertension. Emerging evidence suggests that this drug class may also modulate the tumor microenvironment and enhance the efficacy of immune checkpoint inhibitors.
To address this unmet need, this study aims to explore a novel quadruple-therapy strategy (TACE + tislelizumab + lenvatinib + carvedilol) for the treatment of unresectable HCC with concurrent cirrhotic portal hypertension. The rationale is twofold: while controlling portal hypertension and safeguarding treatment safety, carvedilol may also potentiate immunotherapy by modulating adrenergic signaling, thereby achieving dual benefits of "liver protection" and "anti-cancer" synergy. Utilizing an efficient Simon's two-stage design, this study will conduct a preliminary assessment of the regimen's efficacy and safety with minimal risk, providing essential data to inform future confirmatory research.
Inclusion: 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):; Imaging evidence (ultrasound, CT, or MRI) of portosystemic collateral circulation; Endoscopic evidence of esophageal or gastric varices; 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: Concurrent other malignancies or recurrent HCC; Severe concurrent medical conditions, including asthma, significant cardiac conduction block, and sinus bradycardia; Any active, known, or suspected autoimmune disease; History of allergy to any component of PD-1 inhibitors, lenvatinib, or carvedilol; Known human immunodeficiency virus (HIV) infection; or active hepatitis (e.g., hepatitis B/C virus infection); Decompensated cirrhosis; Presence of tumor thrombus in the inferior vena cava, hepatic vein, or main portal vein.