advanced hepatocellular caricinoma
Conditions
Interventions
One course of chemotherapy represented 2 weeks. 5FU (300 mg/m2/24h) was administered using a mechanical infusion pump on days 1-5 of the first and second weeks. Recombinant interferon alfa-2b 3*106
Sponsors
Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of HCC was confirmed histopathologically or clinically. 2) no adaptation of resection, liver transplantation and local abration. 3) no response to low dose FP 4) without uncontrollable ascites 5) without hepatic coma 6) PS 0-1 7) chronic hepatitis or Child-Pugh A or B 8) WBC > 3000/mm3 Plt > 80000/mm3 Hb > 10.0 g/dl Total Bilirubin < 2.0 mg/dl Albumin > 3 g/dl Creatine < 1.2mg/dl Prothromin time > 60 percentage
Exclusion criteria
Exclusion criteria: 1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or IFN. 7) With severe bone marrow supression. 8) With pulmonary fibrosis. 9) with shosaikoto 10) with autoimmune hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) overall survival 2) time to progression 3) safety | — |
Countries
Japan
Outcome results
None listed