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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Hui-Chuan Sun, Fudan University
ClinicalTrials.gov Identifier:
NCT00838968
First received: February 6, 2009
Last updated: August 21, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Fudan University:

Primary Outcome Measures:
  • 5-years survival rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hui-Chuan Sun, Liver cancer institute, Fudan University
ClinicalTrials.gov Identifier: NCT00838968     History of Changes
Other Study ID Numbers: LCI
Study First Received: February 6, 2009
Last Updated: August 21, 2012
Health Authority: China: Ethics Committee

Keywords provided by 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
Interferon-alpha
Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014