NCT03253250

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis b
• Hepatic Carcinoma

Interventions

Type	Name	Description
DRUG	ETV；TDF；ADV	NAs
DRUG	Peginterferon Alfa-2a	peginterferon

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2017-08-17
• Last updated: 2017-09-08

Locations

1 site across 1 country: China