A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- The patient has histologically or cytologically confirmed, unresectable HCC

- The patient has at least one target lesion measurable according to Response
Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not
lay within a previously irradiated, ablated, or chemoembolized area. If a lesion
does lie in such an area, there must be evidence of growth on successive imaging
studies, including tumor hypervascularity, in order for such a lesion to be
considered a target lesion

- The patient has not received prior systemic therapy for HCC. Patients may have
received prior embolization, chemoembolization, intra-arterial chemotherapy infusion,
ethanol injection, radiofrequency ablation, or cryosurgery

- The patient has fasting serum glucose < 160 mg/dL or below the ULN and/or hemoglobin
A1C < 7%. If baseline nonfasting glucose < 160 mg/dL, fasting glucose measurement is
not required

- The patient has the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- The patient has brain metastases

- The patient has acute hepatitis

- The patient has poorly controlled diabetes mellitus. Patients with a history of
diabetes mellitus are allowed to participate, provided that their blood glucose is
within normal range and that they are on a stable dietary or therapeutic regimen for
this condition

- The patient has congestive heart failure > class II NYHA, unstable angina pectoris,
new onset of angina pectoris, myocardial infarction within the past 6 months, or
cardiac ventricular arrhythmias requiring antiarrhythmic therapy

- The patient has experienced a hemorrhage or bleeding event ≥ NCI-CTCAE Grade 3 within
4 weeks prior first dose of study therapy