Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00149565
First received: September 7, 2005
Last updated: December 15, 2005
Last verified: December 2004
  Purpose

* 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 Intervention Phase
Hepatocellular Carcinoma
Drug: IFN-α2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group

Further study details as provided by National Health Research Institutes, Taiwan:

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

Estimated Enrollment: 268
Study Start Date: October 1997
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by National Health Research Institutes, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149565     History of Changes
Other Study ID Numbers: T1297
Study First Received: September 7, 2005
Last Updated: December 15, 2005
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on July 24, 2014