Hepatocellular carcinoma
Conditions
Interventions
S-1 80%dose 2weeks on, 1week off Sorafenib 800mg/day everyday
Sponsors
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have been diagnosed with hepatocellular carcinoma by histologically or typical diagnostic images 2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy) 3)Systemic chemotherapy naive 4)At least 1 target lesion measurable 5)Performance status (ECOG scale): 0,1 6)Age >= 20 years 7)Adequate bone marrow, liver, renal and cardiac function as assessed by the following (a)Neutrophil >= 1500/mm3 (b)Hemoglobin >= 9.0 g/dl (c)Platelets >= 50000/mm3 (d)Total bilirubin < 3.0mg/dl (e)Liver transaminases <= 10 x Upper limit of Normal(ULN) (f)ALB >= 2.8 g/dl (g)Cre <= ULN (h)PT >= 40% 8)Child-pugh A 9)Patients can take food and drugs oral 10)Life expectancy of at least 12 weeks 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Previous therapy for hepatocellular carcinoma within 30days before study entry 2)Major surgery within 30 days before study entry or surgery within 15 days before study entry 3)Portal vein tumor thrombus in the main trunk 4)Uncontrollable hypertension 5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics 6)get an albumin preparation or a blood transfusion within 30 days before study entry 7)Hepatoencepharopathy. Brain lesions with clinical symptoms 8)Central nerve system tumor(including brain metastasis) 9)Bone metastasis with clinical symptoms 10)Active infection(except HBV and HCV infection) 11)Evidence of serious gastrointestinal bleeding within 30days before study entry 12)Gastro-esophageal varices requiring preventive treatment 13)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment 14)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence) 15)Severe hypersensitivity of TS-1 or sorafenib 16)Severe complication 17)Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Response rate Disease control rate Incidence of adversed effect | — |
Countries
Japan
Contacts
Public ContactYoshihiko Ooka
Chiba University Department of medicine and clinical oncology
Outcome results
None listed