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

This study has been withdrawn prior to enrollment.
(we have found another marker (microRNA26) which is more sensitive to evaluate the effect of postoperative IFNa treatment in patients with HCC)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838968
First Posted: February 9, 2009
Last Update Posted: August 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hui-Chuan Sun, Fudan University
  Purpose
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 Intervention
Hepatocellular Carcinoma Drug: interferon-alpha

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hui-Chuan Sun, Fudan University:

Primary Outcome Measures:
  • 5-years survival rate [ Time Frame: 5 years ]

Enrollment: 0
Study Start Date: January 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838968


Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Hui-chuan Sun, MD Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
  More Information

Responsible Party: Hui-Chuan Sun, Liver cancer institute, Fudan University
ClinicalTrials.gov Identifier: NCT00838968     History of Changes
Other Study ID Numbers: LCI
First Submitted: February 6, 2009
First Posted: February 9, 2009
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Hui-Chuan Sun, Fudan University:
hepatocellular carcinoma
interferon-alpha
p48

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs