The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma

NCT ID: NCT00838968

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.

Detailed Description

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BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC.

METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed.

Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.

Conditions

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Hepatocellular Carcinoma

Keywords

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hepatocellular carcinoma interferon-alpha p48

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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interferon-alpha (IFN-alpha)

the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months

Group Type ACTIVE_COMPARATOR

interferon-alpha

Intervention Type DRUG

interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months

control

no interventions were assigned

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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interferon-alpha

interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Interferon α1b for Injection SINOGEN

Eligibility Criteria

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Inclusion Criteria

* Patients with p48 Positive who underwent a curative resection of HCC

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Hui-Chuan Sun

Liver cancer institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui-chuan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China

Other Identifiers

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LCI

Identifier Type: -

Identifier Source: org_study_id