P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Hepatocellular Carcinoma

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
- surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
- 20 years old or more.
- Eastern Cooperative Oncology Group Performance status of 0 or 1.
- Life expectancy of at least 6 months at the pre-treatment evaluation.
- Child-Pugh class A or B.
- Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
white blood cell count >= 2000/microliter, Neutrophil >= 1000/microliter, Hemoglobin >= 9.0 g/dL, Platelet count >= 75000/microliter, Total Bilirubin <= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) <= 150 IU/L, Serum creatinine <= 1.2mg/dL, Creatinine clearance >= 60 ml/min
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Exclusion Criteria:
- Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
- Extrahepatic tumor spread which affects patient's prognosis.
- Hepatic encephalopathy
- Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Active double cancer
- Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.
11) others, in the investigator's judgment.
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Sites / Locations
- Osaka University, Graduate School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Interferon Alfa、Fluorouracil
Cisplatin、Fluorouracil
Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks