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.

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Key information

Conditions

Cirrhosis, Liver Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Fibrosis HEPATITIS B CHRONIC Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Hepatocellular Carcinoma (HCC) Infections Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biejia-Ruangan compound

Drug

receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy

Biejia-Ruangan compound simulant

Drug

receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy

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

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

Secondary outcomes

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

Time frame: From enrollment to the end of treatment at 96 weeks
- Liver-related death;
- Incidence of non-HCC events and non-liver-related death;
- Changes in liver function, liver fibrosis degree, and tumor markers;
- Trends in the four diagnostic methods of traditional Chinese medicine and changes in TCM syndrome scores;
- Incidence of adverse events (AEs) and serious adverse events (SAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Fan

CONTACT

[email protected]

020-62786534

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

Beijing 302 Hospital
Beijing Ditan Hospital
Shenzhen Third People's Hospital

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 18, 2026
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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