Advanced hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma 2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization. 3) Child-Pugh A or B 4) >=20 years old 5) ECOG Performance Status 0-2 6) oral intake is possible 7) any extrahepatic lesions 8) more than one measurable disease 9) Adequate baseline organ function: neutrophil > 1,500/mm3, hemoglobin >=8.5g/dl, platelets > 75,000/mm3, serum bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <2.0mg/dL 10) written informed consent
Exclusion criteria
Exclusion criteria: 1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change 2) previous therapy for hepatocellular carcinoma within 30 days 3) preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy) 4) inadequate for administration of interferon, 5-FU or cisplatin 5) active double cancer 6) severe complication 7) refractory ascites or pleural effusion 8) inappropriate for entry onto this study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, tumor control rate, safety, translational research | — |
Countries
Japan
Contacts
Faculty of Medical Sciences, University of Fukui Second Department of Internal Medicine