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

Sponsor
Fudan University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00838968
Collaborator
(none)
0
Enrollment
2
Arms
60
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma
Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: interferon-alpha (IFN-alpha)

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

Drug: interferon-alpha
interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months
Other Names:
  • Recombinant Human Interferon α1b for Injection
  • SINOGEN

    		•
    No Intervention: control

    no interventions were assigned

    Outcome Measures

    Primary Outcome Measures

    1. 5-years survival rate [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with p48 Positive who underwent a curative resection of HCC
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Hui-chuan Sun, MD, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui-Chuan Sun, Liver cancer institute, Fudan University
    ClinicalTrials.gov Identifier:
    NCT00838968
    Other Study ID Numbers:
    • LCI
    First Posted:
    Feb 9, 2009
    Last Update Posted:
    Aug 23, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Hui-Chuan Sun, Liver cancer institute, Fudan University
    hepatocellular carcinoma
    interferon-alpha
    p48
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Interferons
    Interferon-alpha

    Study Results

    No Results Posted as of Aug 23, 2012