HCC
Conditions
Interventions
Sorafenib
Low-doseFP+Sorafenib
Sponsors
SILIUS Trial Group,Japan Ministry of Health, Labour and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 Years and older. 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography. 4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5) ECOG Performance status of 0 or 1. 6) Cirrhotic status of Child-Pugh class A. 7) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: a) Hemoglobin >= 8.5 g/dl b) Granulocyte >= 1500/mm3 c) Platelet count >= 50,000 /mm3 d) PT-INR <= 2.3 e) Total serum bilirubin <= 2 mg/dl f) AST and ALT <= 6 times upper limit of normal g) Serum creatinine <= 1.5 times upper limit of normal h) Amylase <= 2 times upper limit of normal 8) Written Informed Consent must be obtained.
Exclusion criteria
Exclusion criteria: 1) Previous malignancy 2) Renal failure 3) Any heart disease as follows a) Congestive heart failure defined as NYHA class III or IV b) Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening c) Serious cardiac arrhythmia d) Serious hypertension 4) Active clinically serious infections except for HBV and HCV 5) Active chicken pox. 6) Auditory disorder. 7) Known history of HIV infection. 8) Known metastatic or meningeal tumors. 9) Extrahepatic tumor spread which affects patient's prognosis 10) History of seizure disorder. 11) Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. 12) Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization. 13) Any history of treatment as follows: a) Treatment with the agent which induces CYP3A4 b) Surgical procedure within 4 weeks prior to start of study drug c) History of organ allograft 14) Patients unable to swallow oral medications. 15) Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics. 16) Medication that may affect to the absorption of drug or pharmacokinetics. 17) Any disease or disorder that may affect the evaluation of study drug. 18) Entry to the other clinical trial within 4 weeks prior to entry to this study. 19) Pregnant or breast-feeding patients. 20) Known allergy to the investigational agent or any agent given in association with this trial. 21) Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results. 22) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Objective Response Rate Tumor markers Safety Biomarker predicting the efficacy | — |
Countries
Japan
Contacts
Public ContactKazuomi Ueshima
Kinki University Faculty of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed