A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- Patients > 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients with histological or cytologically documented HCC

- Patients must have at least one tumor lesion that meets both of the following
criteria:

- The lesion can be accurately measured in at least one dimension according to
RECIST

- The lesion has not been previously treated with local therapy

- Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status)
of 0 or 1

- Cirrhotic status of Child-Pugh class A.

- Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the
study at any time.

Exclusion Criteria:

- History of cardiac disease: congestive heart failure > New York Heart Association
(NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring
anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled
hypertension. Myocardial infarction more than 6 months prior to study entry is
permitted.

- Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's
syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal
slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an
abnormal corneal sensitivity test (Schirmer test or similar tear production test).

- History of interstitial lung disease (ILD).

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry.

- Previous treatment with yttrium-90 spheres

- Any condition that is unstable or which could jeopardize the safety of the patient
and his/her compliance in the study.

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