Hepatocellular carcinoma
Conditions
Interventions
Half dose Sorafenib and UFT
Sorafenib
Sponsors
Hanshin Association of Molecular Targeted Therapy for HCC
Osaka City University Hospital Osaka Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or clinically diagnosed hepatocellular carcinoma (HCC). 2)No indication for surgical resection, local ablation or transarterial chemoembolization refractory or inability 3)Child-Pugh A. 4)Age of 20 years or more. 5)ECOG Performance Status of 0 or 1. 6)Surgical treatment and ablation for hepatocellular carcinoma more than 4 weeks before registration. 7)Maintained function of Cardia, kidney and bone marrow,and satisfying the following: In tests performed 14 or fewer days before enrollment a.White Blood Cell count >=3,000/mm3 b.Platelet count >=5,0000/uL c.hemogrobin level >= 8.0 g/dL d.Total bilirubin < 2.0 mg/dL e.Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range f.Prothrombin time activity >= 50% g.Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range h.No abnormality in ECG requiering for treatment 8)At least 3 month survival expected. 9)Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Vascular invasion 2) Obstruction in the hepatic artery 3) Sever complication such as belows a.cardiac failure b.renal failure c.active infection (except for viral hepatitis) d.active bleeing in gastrointestinal tract e.active other cancer f.Hepatic encepharopathy or severe Mental disorder 4)High fever more than 38 degrees C 5)Not only pregnant or lacting women, but women with suspected pregnancy 6)Inappropriate patients for this study judged by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, response rate, rate of overall recurrence, rate of local recurrence, post treatment response rate of Sorafenib, drop out rate of the treatment, relative dose intensity, safety, tumor markers | — |
Countries
Japan
Contacts
Public ContactHiroki Nishikawa
Hyogo College of Medicine Division of Hepatobiliary and Pancreatic Disease
Outcome results
None listed