Hepatocellular carcinoma
Conditions
Interventions
The combination therapy of TS-1 and Sorafenib
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have been diagnosed with hepatocellular carcinoma by histologycally 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)At least 1 target lesion measurable 4)Performance status (ECOG scale): 0,1 5)Age >= 20 years 6)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% 7)Child-pugh A 8)Patients can take food and drugs oral 9)Life expectancy of at least 12 weeks 10)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 thrombs in the main trunk 4)Uncontrollable hypertension 5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics 6)Hepatoencepharopathy. Brain lesions with clinical symptoms 7)Central nerve system tumor(including brain metastasis) 8)Bone metastasis with clinical symptoms 9)Active infection(except HBV and HCV infection) 10)Evidence of serious gastrointestinal bleeding within 30days before study entry 11)Gastro-esophazeal varices requiring preventive treatment 12)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment 13)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence) 14)Severe hypersensitivity of TS-1 or sorafenib 15)Severe complication 16)Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incident of dose limiting toxcity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adversed event Response rate Disease control rate Time to progression Progression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactYoshihiko Ooka
Chiba University Hospital Gastroenterology
Outcome results
None listed