Inclusion Criteria:

1. Subjects aged 18 years and above, both genders.

2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)

3. No fibrolamellar subtype HCC

4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC

5. Not eligible for Transarterial chemoembolization (TACE ).

6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA)
that were used for HCC, are permitted.

7. Not a candidate for curative surgical resection or liver transplantation

8. Measurable disease defined by the identification at least 1 measurable lesion by
MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging
post-procedure to be considered measurable disease.

9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)

10. Child's Pugh classification A

11. ECOG performance status 0-1

Exclusion Criteria:

1. Patients progressing to liver failure.

2. No core biopsy within the past 7 days

3. Patients who are eligible for Transarterial Chemoembolization (TACE)

4. Patients on concurrent anti-neoplastic therapy (including interferon)

5. Patients who have received any systemic anti-neoplastic therapy not approved for the
treatment of HCC.

6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or
inhaled steroids

7. Presence of metastasis.