advanced hepatocellular carcinoma
Conditions
Interventions
Enrolled patients will be randomly assigned to receive combined 5-FU and PEG-IFN alpha-2b or sorafenib. In the 5-FU and PEG-IFN alpha -2b group, after insertion of the drug delivery system, patients
Schering-Plough, Osaka, Japan) and intra-arterial infusion of 5-FU (Kyowa Hakko, Tokyo, Japan). One treatment cycle lasts 4 weeks. PEG-IFN alpha-2b dose is weight-adjusted and administered subcutane
Sponsors
Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for treatment were as follows: 1) Portal vein tumor thrombosis (PVTT) grade Vp2-Vp4; 2) no indications for radiotherapy, surgical resection or nonsurgical interventions such as radiofrequency ablation (RFA), microwave coagulation therapy (MCT), percutaneous ethanol injection (PEI) or trans-hepatic arterial chemoembolization (TACE); 3) age >20 years; 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS)4 level 0-2; 5) no uncontrollable ascites or pleural effusion; 6) platelet count >50000/mm3, leukocyte count >2000/l, total bilirubin <3 mg/dl, and serum creatinine <1.5 mg/dl; and 7) chronic hepatitis (CH) or compensated liver cirrhosis (LC) with a Child-Pugh class of A or B.
Exclusion criteria
Exclusion criteria: Exclusion criteria for treatment were as follows:1) pregnancy women 2) patients who had allergic disorder and severe disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Countries
Japan
Outcome results
None listed