hepatocellular carcinoma
Conditions
Interventions
Sponsors
Kanazawa University Hospital
Eligibility
Sex/Gender
All
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 4) >=20 years old 5) ECOG Performance Status 0-2 6) oral intake is possible 7) no extrahepatic lesion 8) no preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy) 9) more than one measurable disease 10) 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 11) written informed consent 12) life expectancy >=3 months
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 sorafenib, 5-FU, cisplatin or interferon 5) active double cancer 6) severe complication 7) refractory ascites of 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 |
|---|---|
| Progression free survival Response rate Tumor control rate Adverse events | — |
Countries
Japan
Contacts
Public ContactTatsuya Yamashita
Kanazawa University Hospital Department of Gastrenterology
Outcome results
None listed