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

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

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.

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