|Inclusion Criteria:||1) Signed Written Informed Consent: a) Voluntary signed and dated written informed consent form in accordance with regulatory and institutional guidelines obtained before the performance of any protocol-related procedures not part of normal patient care.|
2) Target Population: a) Patients with diagnosis of hepatocellular carcinoma (HCC) meeting the criteria below: i) Biopsy-proven HCC (histology or cytology), OR ii) IF Alpha fetoprotein > 400 ėg/L at the time of diagnosis, require: 1. Radiological evidence of HCC showing lesion arterial hypervascularity and venous phase washout by either dynamic (triplephase), contrast-enhanced computed tomography of the abdomen or dynamic (triple-phase) contrast (gadolinium)-enhanced MRI, AND 2. Serology positive for hepatitis B or C, or cirrhosis,
3) (Continuation of crit # 2) OR iii) IF Alpha fetoprotein =/< 400 ug/L at the time of diagnosis, require: 1. Dynamic (triple-phase), contrast-enhanced computed tomography of the abdomen, AND 2. Dynamic (triple-phase) contrast (gadolinium)-enhanced MRI. BOTH CT and MRI should show radiological evidence of HCC lesion arterial hypervascularity and venous phase washout.
4) (Continuation of crit # 3) b) For HCC with less than four lesions, at least one must have a diameter =/> 5 cm OR if four or more lesions, at least one must have a diameter =/> 2 cm; c) Cirrhotic status of Child-Pugh Class A or B with a score of 7; d) ECOG performance status of 0 or 1; e) Life expectancy of at least 12 weeks; f) Ability to comply with visits/procedures required by protocol.
5) Physical and Laboratory Test Findings: a) Adequate hematologic function with absolute neutrophil counts >/= 1,500/mm^3, platelet count >/= 60 x 10^9/L, and hemoglobin >/= 8.5 g/dL; b) Adequate hepatic function with serum total bilirubin </= 3 mg/dL, serum albumin >/= 2.8 g/dL, and ALT and AST </= 5 times the institutional upper limits of normal (ULN); c) Amylase and lipase < 1.5 times the institutional upper limit of normal; d) Adequate renal function with serum creatinine </= 2.0 mg/dL
6) (Continuation of crit # 5) e) International normalized ratio (INR) < 1.7 or prothrombin time (PT) < 4 seconds above control; f) Left ventricular ejection fraction (LVEF) >/= 50% as measured by 2-D echocardiogram; g) All laboratory test finding should be stable within the range listed in a) - f) without continuous supportive treatment, such as blood transfusion, coagulation factors and/or platelet infusion, red/white blood cell growth factor administration, or albumin infusion, etc.
7) Age and Sex: a) Men and women, ages 18 or older. b) Women of childbearing potential (WOCBP), WOCBP whose male partners receive study drug, and male patients must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.
8) (Continuation of crit # 6) Post menopause is defined as: Amenorrhea >/= 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL.
9) (Cont of # 7) Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
10) (Cont of # 8) In the case of urine pregnancy testing, a serum sample for pregnancy testing must also be obtained within 72 hours prior to start of investigational product to confirm the urine results. Investigational product may be initiated prior to the confirmatory serum pregnancy test results being available.