Spots Global Cancer Trial Database for A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
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Trial Identification
Brief Title: A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
Official Title: A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks
Study ID: NCT05671315
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Public Health Clinical Center Of Chengdu, Chengdu, , China
The First Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Tongren Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, , China
The Fifth People's Hospital Of Suzhou, Suzhou, , China
Xiamen Hospital of Traditional Chinese Medicin, Xiamen, , China
The Tirth Affiliated Hospital Of Xinxiang Medical University, Xinxiang, , China
Contact Details
Name: Qing Xie
Affiliation: Ruijin Hospital, Shanghai
Role: PRINCIPAL_INVESTIGATOR
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