A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
Status:
Active, not recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world.
hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up
to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can
significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with
chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control
the disease. However, studies in recent years have found that long-term therapy with
Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients
with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad
have shown that compared with long-term oral NAs, peginterferon can significantly reduce the
risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is
limit prospective studies.
This multicenter, randomized, open-label, controlled trial study is aim to evaluate the
pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of
hepatocellular carcinoma, to provide evidences for new management and treatment strategy
options for improving clinical outcomes for the chronic hepatitis B patients. About 267
chronic hepatitis patients with intermediate to high risk of liver cancer who are now
receiving nucleoside therapy will be enrolled. Subjects will be randomized into the
peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of
HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver
cirrhosis and hepatocellular carcinoma will be assessed.