Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study

N/ANot Yet RecruitingNCT07481032

Nanfang Hospital, Southern Medical University1,034 enrolled

Overview

This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,034

Conditions

Cirrhosis, Liver Hepatocellular Carcinoma (HCC)HEPATITIS B CHRONIC

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Voluntarily signed informed consent form * Aged 18-65 years * Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu * Meeting the diagnostic criteria for hepatitis B-related cirrhosis * aMAP score \> 60 Exclusion Criteria: * \[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies * Pregnant or lactating women * Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding) * Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury * Severe cardiac, renal, respiratory, or hematopoietic system diseases * Determined by the investigator to be unsuitable for participation in this trial

Outcomes

Primary Outcomes

Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up

Time frame: From enrollment to the end of treatment at 96 weeks

Secondary Outcomes

Non-HCC liver-related events and other the clinical changes or incidence rates

1. Liver-related death; 2. Incidence of non-HCC events and non-liver-related death; 3. Changes in liver function, liver fibrosis degree, and tumor markers; 4. Trends in the four diagnostic methods of traditional Chinese medicine and changes in TCM syndrome scores; 5. Incidence of adverse events (AEs) and serious adverse events (SAEs).