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A Phase III Study in Post-Operative HBV-Related Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital,Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
Changhua Christian Hospital
National Cheng-Kung University Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00455091
First received: April 2, 2007
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  Purpose

Research Objective and Study End Points To evaluate the anti-HBV as well as HCC recurrence reducing effects of standard (18 months) lamivudine treatment at time of HBV reactivation with hepatitis flare up (HBV DNA > 105 copies/mL and ALT level > 2.0 x UNL) or prophylactic, prolong (36 months) adefovir dipivoxil therapy in post-operative HBsAg(+),< 5 cm HCC patients, and to compare the results of who group with historical controls (T1297, HBsAg+,< 5 cm HCC cohort),in terms of the following endpoints.

  1. Primary endpoint:

    the 3-years recurrence rate (excluding those recur within first year).

  2. Secondary endpoints:

the first 2 year tumor recurrence rates the recurrence-free survival the overall survival. anti-viral efficacy, i.e. biochemical response and viral response rate. to correlate the changes of viral titer with the clinical outcome in post- operative HCC patients with adjuvant lamivudine or adefovir therapy.


Condition Intervention Phase
Hepatocellular Carcinoma
 Drug: Adefovir Dipivoxil and Lamivudine
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomization Trial of Adjuvant Lamivudine/ Adefovir Dipivoxil Against Recurrence in Post-Operative HBV-Related Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Primary endpoint: Primary endpoint: the 3-years recurrence rate (excluding those recur within first year). [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary endpoints: the first 2 year tumor recurrence rates,the recurrence-free survival,the overall survival.anti-viral efficacy. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

HBVDNA


Estimated Enrollment: 309
Study Start Date: May 2007
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adefovir Dipivoxil and Lamivudine
    Adefovir Dipivoxil 10mg/day x 36 months,Lamivudine 100 mg/day x 18 months#, when HBV DNA =/> 105 copies/mL and ALT > 2.0 x UNL
    Other Name: Hepsera,Zeffix
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Post-operative HBV-related Hepatocellular Carcinoma

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. Tumors, either single, < 5 cm in size or no more than 3 for size < 3 cm.
  5. Patients must have a performance status of ECOG score < 2.

  6. Patients must have adequate liver reservation and adequate hemogram.

    • Pugh-Child's Score < 7.
    • The serum total bilirubin level are < 2 mg/dl.
    • The prothrombin times are < 3 sec above normal control.
    • The platelet are > 7.5 x 104 / mm3.
    • The WBC are > 3,000 / mm3.
  7. Patient must have serum creatinine < 1.5 mg/dl
  8. Cardiac function with NYHA classification < Grade II
  9. HBsAg (+) .
  10. 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 glucoticosteroid or immunosuppressant agent(s) are not eligible.
  5. Patients with advanced second primary malignancy are not eligible.
  6. Patients with pregnancy 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.
  10. Patients who had prior lamividine and/or adefovir dipivoxil therapy are not eligible.
  11. Anti-HCV positive patients are not eligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455091

Locations
Taiwan
Veterans General Hospital-Kaohsiung
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital
Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital (Lin-Kou)
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Veterans General Hospital-Taipei
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital,Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
Changhua Christian Hospital
National Cheng-Kung University Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Investigators
Principal Investigator: Li-Tzong Chen, Ph.D. National Health Research Institutes, Taiwan
Principal Investigator: Pei-Jer Chen, Ph.D. National Taiwan University Hospital
Study Chair: Miin-Fu Chen, M.D. Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: National Health Research Instiutes, Taiwan, National Institute of Cancer Research
ClinicalTrials.gov Identifier: NCT00455091     History of Changes
Other Study ID Numbers: T1206
Study First Received: April 2, 2007
Last Updated: June 29, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Post-operative Hepatocellular Carcinoma.

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
Adefovir
 Adefovir dipivoxil
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013