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

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

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
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine

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.