Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Chang Gung Memorial Hospital; China Medical University Hospital; Mackay Memorial Hospital; National Taiwan University Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Interferon alpha-2

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.