Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy

Inclusion Criteria:

   - Prior diagnosis of HCC confirmed histologically.

   - Prior treatment with at least 1 systemic agent, with documented progressive disease
   after systemic agent(s), or adverse event(s)associated with prior systemic agent(s)
   that resulted in discontinuance of that agent(s).

   - Cirrhotic status of Child-Pugh grade B7.

   - Expected survival of at least 3 months.

   - Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

   - Candidate for potential curative therapies (i.e., resection or transplantation) or
   loco-regional approaches (i.e., ablation, embolization).

   - Significant cardiac disease.

   - Serious infection requiring treatment with systemically administered antibiotics.

   - Pregnancy or lactation.

   - Expected non-compliance.

   - Uncontrolled intercurrent illness, or psychiatric illness or social situations that
   would limit compliance with study requirements.

   - Subjects who have had any anticancer treatment within 2 weeks prior to entering the
   study.

   - Subjects who have not fully recovered from toxicities associated with previous HCC
   loco-regional or systemic therapies.

   - Subjects with history of another primary cancer, with the exception of: a) curatively
   resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ;
   or c) other primary solid tumor with no known active disease present in the opinion of
   the investigator will not affect patient outcome in the setting of current HCC
   diagnosis.

   - Allergy to pegylated products.

   - Bleeding esophageal or gastric varices within the prior three months, except if banded
   or treated.

   - Subjects known to be HIV positive.

   - Uncontrolled ascites (defined as not easily controlled with diuretic treatment).

   - Having received any blood transfusion, blood component preparation, erythropoietin,
   albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days
   prior to screening laboratories or after screening laboratories have been obtained
   until first dose of study drug or placebo.

   - Use of traditional medicines approved by local authorities, including but not limited
   to Chinese herbs within 14 days of first dose of study drug or placebo.

   - ECOG performance status > 2.

   - Prior allograft,including liver transplant.