hepatocellular carcinoma with extrahepatic metastases
Conditions
Interventions
Two weeks represented one cycle of treatment. In each cycle, S-1 was administered orally at a dose of 80-120 mg daily (depending on body surface area: <
1.25 m2, 80 mg
1.25-1.5 m2, 100 mg
&
1.5 m2, 120 mg), and CDDP was administered intravenously at a dose of 60 mg/m2 on day 8. Each treatment cycle was followed by a two-to-four-week rest period of no treatment. Treatment was repeatec un
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) with extrahepatic metastases 4) without uncontrollable ascites 5) without hepatic coma 6) without vascular invasion of HCC 7) PS 0-1 8) chronic hepatitis or Child-Pugh A or B 9) 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, TS-1 or IFN. 7) With severe bone marrow supression. 8) With pulmonary fibrosis. 9) With another fluoropyrimidine 10)With flucytosine 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