Biomarker Analysis in Sorafenib Treated Hepatocellular Carcinoma Patients

Inclusion criteria

• Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein > 400ng/mL and liver cirrhosis
• Inoperable disease as defined by (Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR Presence of extra-hepatic disease OR Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR The HCC must not be amenable to intra-arterial therapy or local ablative therapy)
• Minimum life expectancy of 12 weeks
• Age > 18 years.
• ECOG Performance Status of ≤ 2
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

(Hemoglobin > 9.0 g/dl,Absolute neutrophil count>1,500/mm3, Platelet count>75,000/μl,Total bilirubin < 1.5 times the upper limit of normal,ALT and AST < 5 x upper limit of normal,Albumin ≥ 3g/dL,PT-INR/PTT < 1.5 x upper limit of normal,Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥ 50mL/min)

• Signed and dated informed consent before the start of specific protocol procedures.
• FNA will be performed in patients with feasible biopsy site

Exclusion criteria

• Decompensated cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
• Other concomitant anticancer agent, including Tamoxifen and Interferon
• Active clinically serious infections (> grade 2 CTCAE version 3.0)
• History of organ allograft
• Patients with evidence or history of bleeding diasthesis
• Patients undergoing renal dialysis
• Radiotherapy during study or within 4 weeks of start of study drug.
• Prior exposure to the study drug.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results