advanced hepatocellular carcinoma
Conditions
Interventions
Level 1: Sorafenib 400mg/day + UFT 300 mg/day Level 2: Sorafenib 800 mg/day + UFT 300 mg/day Level 3: Sorafenib800 mg/day + UFT 400 mg/day Orally intake both sorafenib and UFT for 28 days as one
Sponsors
Kyushu Univrsity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histology/cytology-or clinically (by imaging or tumor marker) proven hepatocellular carcinoma 2)no indication for locoregional therapy, hepatectomy, radiofrequency ablation therapy, chemoemblization or ethnol injection therapy 3) Patients who have target lesions that can be measured with imaging CT or imaging MRI. 4) No carry-over effect or adverse drug reaction of prior treatments. Make following intervals from previous treatments; 2 weeks from a surgery and percutaneous local therapy, 4 weeks from transarterial chemoembolization, transcatheter arterial infusion and radiations. 5) Child-Pugh A 6)ECOG performance status of 0-1 7) The function of the major organ is kept as satisfied by the following requirement (within 14 days before study entry), Neutrophil >= 1,500/microL Platelets >= 50,000/microL Hemoglobin >= 10g/dL Total bilirubin < 2.0mg/dL AST or ALT <= 5 *Upper limit of Normal(ULN) Cr <= 1.5 *ULN 8) Age >= 20 years at informed consent. 9) Patients are considered to keeping procedure of this study such as visit, compliance, having laboratory tests. 10)Acquisition of written informed consent
Exclusion criteria
Exclusion criteria: 1) Treatment with sorafenib or other molecular target drugs in past. 2) Any systemic chemotherapy in past. 3) Patients with ascites possessed clinical meaning. (Requiring drainage) 4) After liver transplantation 5) Esophageal varices with bleeding risk 6) Within 12 months before study entry, following events were happened; acute myocardial infarction, unstable angina, heart failure, cerebrovascular diseases. 7) Hepatic Encephalopathy. (Including as a previous disease) 8) Brain tumors. 9) Hemodialysis. 10) Gastrointestinal bleeding was happened within 1 month before study entry. 11) Active second primary malignancies. 12) Treating with CYP3A4 inducing agents. (rifampicin, etc.) 13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension 14) Contraindication of UFT and sorafenib 15) Patient with taking herbal medicine approved as a treatment of cancer. (shosaikoto, etc.) 16) Patients with infection of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases. 17) Any patients are pregnant/ nursing 18)Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose and recommended dose of sorafenib and UFT | — |
Countries
Japan
Contacts
Public ContactKen Shirabe
Kyushu University Department of Surgery and Science, Graduate School of Medical Sciences
Outcome results
None listed