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

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interferon-alpha
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, interferon-alpha, p48

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    interferon-alpha (IFN-alpha)

    control

    Arm Description

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

    no interventions were assigned

    Outcomes

    Primary Outcome Measures

    5-years survival rate

    Secondary Outcome Measures

    Full Information

    First Posted
    February 6, 2009
    Last Updated
    August 21, 2012
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00838968
    Brief Title
    The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma
    Official Title
    The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    we have found another marker (microRNA26) which is more sensitive to evaluate the effect of postoperative IFNa treatment in patients with HCC
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    October 2012 (Anticipated)
    Study Completion Date
    January 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    hepatocellular carcinoma, interferon-alpha, p48

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    interferon-alpha (IFN-alpha)
    Arm Type
    Active Comparator
    Arm Description
    the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    no interventions were assigned
    Intervention Type
    Drug
    Intervention Name(s)
    interferon-alpha
    Other Intervention Name(s)
    Recombinant Human Interferon α1b for Injection, SINOGEN
    Intervention Description
    interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months
    Primary Outcome Measure Information:
    Title
    5-years survival rate
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with p48 Positive who underwent a curative resection of HCC Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui-chuan Sun, MD
    Organizational Affiliation
    Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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