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TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension

NCT07350070 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol

All the enrolled patients received standard first-line treatment (TACE combined with tiragolumab and lenvatinib) and were additionally treated with carvedilol. The treatment duration of the study was one year. After the end of the treatment, the patients would be evaluated by the researchers to determine whether to continue the treatment or switch to other first-line treatments.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Wanguang Zhang · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350070 on ClinicalTrials.gov