Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma
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Ages Eligible for Study:
20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically proven hepatocellular carcinoma.
HCC underwent curative resection within 6 weeks before registration.
Grossly, the resection margin should be > 1 cm.
Patients must be younger than 70 year-old.
Patients must have a performance status of ECOG score < 2.
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 > 10 x 104 / mm3.
The WBC are > 3,000 / mm3.
Patient must have serum creatinine < 1.5 mg/dl
Cardiac function with NYHA classification < Grade II
Known HBV or HCV status.
Signed informed consent.
Patients who have non-curative resection are not eligible.
Resected HCCs with histologically positive margins are not eligible.
HCCs with radiological evidence of portal vein thrombus are not eligible.
Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
Patients with advanced second primary malignancy are not eligible.
Patients with pregnacy or breast-feeding are not eligible.
Patients with severe cardiopulmonary diseases are not eligible.
Patients with clinically significant psychiatric disorder are not eligible.
Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.