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.

NCT Number	NCT07481032
Lead Sponsor	Nanfang Hospital, Southern Medical University Collaborators: Shenzhen Third People's Hospital, Beijing Ditan Hospital, Beijing 302 Hospital
Conditions	Cirrhosis, Liver, Hepatocellular Carcinoma (HCC), HEPATITIS B CHRONIC
Enrollment	1,034 participants
Start Date	2026-04-01
Primary Completion	2028-04-01 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-18