A Phase III Study in Post-operative HBV-related Hepatocellular Carcinoma

Summary

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.

Conditions

• Hepatocellular Carcinoma

Interventions

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

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Mackay Memorial Hospital

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Changhua Christian Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• Kaohsiung Medical University

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Li-Tzong Chen, Ph.D. · National Health Research Institutes, Taiwan

• Pei-Jer Chen, Ph.D. · National Taiwan University Hospital

• Miin-Fu Chen, M.D. · Chang Gung Memorial Hospital

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2012-04-30

Completion

2018-04-30

Countries

• Taiwan

Study Locations