- 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
- Decompensated cirrhosis or stage C (Index > 10) according to the Child-Pugh
- 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