A Phase III Study in Post-operative HBV-related Hepatocellular Carcinoma
Status:
Terminated
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
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.
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital Changhua Christian Hospital Kaohsiung Medical University Kaohsiung Veterans General Hospital. Mackay Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Taichung Veterans General Hospital Taipei Veterans General Hospital, Taiwan