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UNKNOWNPHASE4

The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

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

NCT03253250•Huashan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female patients with age ≥18 and ≤70 years;
•2. Expected survival time \>3 months;
•3. 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；
•4. The patients have been treated by resection due to HCC;
•5. The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
•6. Child-Pugh scores:A
•7. Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria

•1. Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
•2. Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
•3. Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
•4. BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
•5. History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
•6. Allergic history to interferon;
•7. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
•8. 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);
•9. absolute neutrophil count(ANC)\<1.5x 10\^9/L or platelet count(PLT)\<70x 10\^9/L
•10. Creatinine over upper limit of normal;
+9 more criteria

Locations (1)

Huashan Hospital

Shanghai, China

Key Dates

Start Date

September 1, 2017

Primary Completion Date

June 1, 2019

Completion Date

December 1, 2019

Last Updated

September 8, 2017

Enrollment

432

ESTIMATED participants

Conditions

Chronic Hepatitis bHepatic Carcinoma

Interventions

ETV；TDF；ADV

DRUG

Peginterferon Alfa-2a

DRUG

Contacts

Lunxiu Qin

CONTACT

52887172 qinlx@fudan.edu.cn

Huliang Jia

CONTACT

jbl-1@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

Inclusion Criteria

Exclusion Criteria

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