Hepatocellular carcinoma
Conditions
Interventions
The combination chemotherapy of sorafenib and S-1
Sponsors
Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI and AFP or PIVKA-II is over the institutional upper limit, 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 or 1 6) oral intake is possible 7) no preceded systemic chemotherapy (excluded adjuvant chemotherapy) 8) more than one measurable disease 9) Adequate baseline organ function: neutrophil > 1,500/mm3, hemoglobin >=10.0g/dl, platelets > 75,000/mm3, serum bilirubin <=1.5 times of the institutional upper limit, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <1.5 mg/dL and creatinin clearance >=50ml/min 10) life expectancy >=12 weeks 11) 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 used sorafenib or 5-FU (excluded transcatheter arterial embolization or adjuvant chemotherapy) 4) inadequate for administration of sorafenib or S-1 5) active double cancer 6) active infection (excluded viral hepatitis) 7) water diarrhea 8) severe complication 9) refractory ascites of pleural effusion 10) metastases to central nervous system 11) pregnancy or lactaing females 12) inappropriate for entry onto this study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incident of dose-limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Response rate Time to progression Overall survival | — |
Countries
Japan
Contacts
Public ContactTatsuya Yamashita
Kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed