Hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) hepatocellular carcinoma confirmed histologically or clinically (typical diagnostic images and over the upperlimit of AFP) 2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization 3) aged 20-79 years old 4) measurable or assessable lesion(s) 5) ECOG Performance Status 0-2 6) Adequate organ function a) Neutrophil>=1000 /mm3 b) Hb>= 8.0 g/dL c) PLT>= 50000 /mm3 d) T-Bil<= 3.0 mg/dL e) Albumin>= 2.8 g/dL f) AST<= 150 IU/L g) ALT<= 150 IU/L h) Amylase<= 300 U/L i) Cre<= 1.5 mg/dl 7) Child-Pugh score 5-8 points 8) Interval of at least 4 weeks between last treatment and start of present chemotherapy regimen 9) No prior systemic chemotherapy 10) Written informed consent 11) Life expectancy of at least 8 weeks 12) sorafenib refractory hepatocellular carcinoma
Exclusion criteria
Exclusion criteria: 1)Massive pleural or abdominal effusion 2)Uncontrolled hypertension 3)Uncontrolled heart disease 4)Evidence of Myocardial infarction witin 6 months 5)Active infection (except viral hepatitis) 6)Active gastrointestinal bleeding or ulcer 7)active double cancer 8)encephalopacy or severe mental disorder 9)severe drug allergy 10)pregnancy or lactaing females 11)inadequate for administration orally 12)Inadequate physical condition,as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Recommended Dose Phase II: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Adverse events Response rate Progression free survival | — |
Countries
Japan
Contacts
Public ContactMichio Nakagawa
Chiba University Hospital Depatrment of gastroenterology
Outcome results
None listed