Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Inclusion Criteria:
- Patients newly diagnosed as HCC according to European Association for Study of the
Liver criteria.
- BCLC stage B
- Child-Pugh class A
- ECOG performance status of 0
- Etiology: Hepatitis B virus(HBV) infection
- Written informed consent (approved by the Institutional Review Board [IRB]obtained
prior to any study specific screening procedures
- Patient must be able to comply with the protocol
- Age 18-80 years
- Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L,
Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin
time international normalized ratio < 1.5
- Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of
normal
- Life expectancy of > 3 months
Exclusion Criteria:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper
limit of normal
- Other severe concomitant disease that may reduce life expectancy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
- Uncontrolled hypertension
- Serious, non-healing wound, ulcer, or bone fracture
- Currently or recent (within the 30 days prior to starting study treatment) treatment
of another investigational drug or participation in another investigational study
- Clinically significant (i.e. active) cardiovascular disease for example
cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction (
≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA)
grade II or greater congestive heart failure, serious cardiac arrhythmia requiring
medication
- Evidence of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of Sorafenib/TACE or patient at high risk from treatment
complications