| Inclusion Criteria: | 1) Informed consent must be obtained prior to commencing any study procedure
2) Confirmation of diagnosis of HCC for subjects undergoing a) surgical resection histological confirmation is mandatory (a post surgery pathology report is required for both histological confirmation and risk stratification); b) local ablation either histological confirmation of clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological confirmation is mandatory
3) Confirmation of diagnosis of hepatocellular carcinoma prior to curative treatment, confirmation of a maximum tumor load of: a) single lesion any size for surgical resection, or single lesion less than or equal to 5cm (largest diameter, unidimensional measurement) for local ablation; b) 2-3 lesions, each less than or equal to 3cm in size (largest diameter, undimensional measurement)
4) Patients who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of hepatocellular carcinoma with curative intent within 4 months from staging to potentially curative treatment (resection/ablation). A maximum of 2 local ablation courses may be administered during this time period (if the patient has had ablation for curative treatment, then no more than 2 local ablation courses may be performed)
5) Patients may have undergone resection or last local ablation course 4 weeks (28 days +/- 7 days) , to CT/MRI scan date (post curative treatment)
6) Male or female subjects greater than or equal to 18 years of age
7) Confirmation of complete response (CR) (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review
8) For subjects undergoing surgical resection pathologically clear margins proven complete removal of tumor
9) Intermediate Risk (single tumors 2-3cm in size, longest diameter, unidimensional measure) or High Risk (single tumors greater than 3-5 cm in size or 2 or 3 lesions each less than or equal to 3 cm in size) of recurrence as assessed by tumor characteristics.
10) Child-Pugh score 5-7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites
11) ECOG Performance Status of 0
12) Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 14 days of randomization a)Hemoglobin greater than of equal to 9.0g/dl b)Absolute neutrophil count (ANC) greater than or equal to 1,500/mm(3)Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples approximately 14 days prior to screening a)Hemoglobin greater than of equal to 9.0g/dl b)Absolute neutrophil count (ANC) greater than or equal to 1,500/mm(3)
13) CONTINUED FROM INCLUSION 12 - c) Platelet count greater than or equal to 50,000/ul d) Total bilirubin less than or equal to 2 mg/dL e) ALT and AST less than or equal to 5 times ULN f)Alkaline phosphatase less than or equal to 4 times ULN g) PT greater than 50% or PT-INR less than 2.3, or less than 6 seconds above control h) For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care i) Serum creatinine less than or equal to 1.5 x ULN
14) Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment (assessed centrally)
15) Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial
16) At least 3 weeks (21 days) but not more than 7 weeks (49 days) from resection or last local ablation course, to CT/MRI scan date. A timeframe of 4 weeks after surgical resection or last ablation is recommended |