NCT07350070Not yet recruitingPhase 2
TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 25 Dec 2025
- Start date
- 31 Dec 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Tongji Hospital
- NCT number
- NCT07350070
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 31 Dec 2025 to the primary completion date, 30 Jun 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other malignancies or recurrent HCC.
- Severe concurrent medical conditions, including asthma, significant cardiac conduction block, and sinus bradycardia.
Other illness
- 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).
Other
- Decompensated cirrhosis.
- Presence of tumor thrombus in the inferior vena cava, hepatic vein, or main portal vein.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Department of Hepatobiliary and Pancreatic Oncology Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Shandong First Medical University Affiliated Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Organ Transplant Department,Qilu Hospital, Cheeloo College of Medicine, Shandong University, Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Qingdao University Affiliated Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Hubei Province Tahe Hospital Coordinator of this site? Confirm its status | Taihe | China | Unknown status |
| Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.