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Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00149565
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 16, 2005
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
Tri-Service General Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
China Medical University Hospital
Information provided by:
National Health Research Institutes, Taiwan

Brief Summary:

* OBJECTIVES

  1. To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years recurrence rate in curatively resected HCC .
  2. To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in curatively resected HCC.
  3. To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC with or without cirrhosis.
  4. To investigate the change of activity of HBV and HCV in postoperative HCC patients with adjuvant IFN-α therapy.
  5. To correlate the changes of viral status with the clinical outcome in post-operative HCC patients with adjuvant IFN-α therapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: IFN-α2b Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group
Study Start Date : October 1997
Study Completion Date : July 2005



Primary Outcome Measures :
  1. 134 patients for each of the two treatment arms are needed.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria:

    1. Histologically proven hepatocellular carcinoma.
    2. HCC underwent curative resection within 6 weeks before registration.
    3. Grossly, the resection margin should be > 1 cm.
    4. Patients must be younger than 70 year-old.
    5. Patients must have a performance status of ECOG score < 2.
    6. Patients must have adequate liver reservation and adequate hemogram.
    7. Pugh-Child‘s Score < 7.
    8. The serum total bilirubin level are < 2 mg/dl.
    9. The prothrombin times are < 3 sec above normal control.
    10. The platelet are > 10 x 104 / mm3.
    11. The WBC are > 3,000 / mm3.
    12. Patient must have serum creatinine < 1.5 mg/dl
    13. Cardiac function with NYHA classification < Grade II
    14. Known HBV or HCV status.
    15. Signed informed consent.
  • Exclusion Criteria:

    1. Patients who have non-curative resection are not eligible.
    2. Resected HCCs with histologically positive margins are not eligible.
    3. HCCs with radiological evidence of portal vein thrombus are not eligible.
    4. Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
    5. Patients with advanced second primary malignancy are not eligible.
    6. Patients with pregnacy or breast-feeding are not eligible.
    7. Patients with severe cardiopulmonary diseases are not eligible.
    8. Patients with clinically significant psychiatric disorder are not eligible.
    9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.

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): NCT00149565


Locations
Taiwan
Chang Gung Memorial Hospital
Tao-Yuan, Taiwan, 333
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
Tri-Service General Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
China Medical University Hospital
Investigators
Study Chair: Li-Tzong Chen, Ph.D. Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG
Study Chair: Pei-Jer Chen, Ph.D. Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149565     History of Changes
Other Study ID Numbers: T1297
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: December 2004

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