A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection

Huashan Hospital1 site in 1 country432 target enrollmentSeptember 1, 2017

ConditionsChronic Hepatitis b Hepatic Carcinoma

InterventionsPeginterferon Alfa-2a ETV；TDF；ADV

DrugsETV；TDF；ADV Peginterferon Alfa-2a

Overview

Phase: Phase 4
Intervention: Peginterferon Alfa-2a
Conditions: Chronic Hepatitis b
Sponsor: Huashan Hospital
Enrollment: 432
Locations: 1
Primary Endpoint: Recurrence-free Survival Rate (RFS）
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a

Detailed Description

The subjects who have been treated by resection due to hepatocellular carcinoma (HCC) will be randomized into 2 groups: the subjects in group A will be treated by Nucleotide analogues (NAs)( ETV, 0.5mg，qd；tenofovir disoproxil fumarate(TDF)，300mg，qd；ADV，10mg，qd）for 96 weeks; the subjects in group B will be treated by peginterferon alfa-2a （135μg/week）combination with NAs (ETV\\TDF\\ADV)for 96 weeks.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

December 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huashan Hospital

Responsible Party

Principal Investigator

Jiming Zhang

Deputy director of department

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

•Male and female patients with age ≥18 and ≤70 years;
•Expected survival time \>3 months;
•There should be evidences that chronic hepatitis B or hepatitis have been positive, hepatitis B virus (HBV) DNA detectable or undetectable, Alanine aminotransferase(ALT)\<upper limit of normal (ULN) or ≥ULN；
•The patients have been treated by resection due to HCC;
•The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
•Child-Pugh scores:A
•Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria

•Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
•Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
•Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
•BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
•History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
•Allergic history to interferon;
•Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
•History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
•absolute neutrophil count(ANC)\<1.5x 10\^9/L or platelet count(PLT)\<70x 10\^9/L
•Creatinine over upper limit of normal;