Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

Inclusion Criteria:

* Signed written Institutional Review Board/Ethical Committee approved informed consent form.
* Male or female ≥18 years old.
* Life expectancy ≥3 months.
* ECOG Performance Status of 0-1.
* Histologically confirmed hepatocellular carcinoma.
* Not a candidate for curative treatments.
* Child-Pugh A
* Hematological, Biochemical and Organ Function:

  * AST (SGOT): ≤5.0 × ULN,
  * ALT (SGPT): ≤5.0 × ULN,
  * Total Bilirubin: ≤1.5mg/dL,
  * Platelets: ≥100,000/μL,
  * Absolute Neutrophil Count: ≥1,500/μL,
  * Serum creatinine: ≤2.0 × ULN,
  * PT-INR: ≤2.0
* Ability to provide a tumor tissue sample either by:

  * A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis
  * Undergo a biopsy to confirm HCC diagnosis
* Measurable disease.

Exclusion Criteria:

* Child-Pugh B or C
* Patient who have taken Sorafenib previously.
* Difficulty or inability to swallow pills.
* Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
* Patients known to be positive for Human immunodeficiency virus infection.
* Active infectious diseases requiring treatment except for hepatitis B and C.
* Other malignancies within the last 5 years.
* History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements..
* Patients with known brain metastases or other central nervous system disease/disorders.
* Uncontrolled hypertension defined as systolic blood pressure \>150 mmhg or diastolic blood pressure \>90 mmHg, despite optimal medical management.
* Non-tumor related thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
* Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 3, any other hemorrhage/bleeding event ≥ CTCAE Grade 4 within 4 weeks of first dose of study drug.
* Serious non-healing wound, ulcer, or bone fracture.
* Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1(6 weeks for nitrosoureas, mitomycin, and bevacizumab; 1 week for tumor biopsy).
* Patients who received the following treatments within 2 weeks prior to Day 1:

  * Anticoagulant or thrombolytic agents for therapeutic purposes,
  * Systemic anti-viral therapy for hepatitis C and Interferon therapy for hepatitis B,
  * Blood transfusion including all blood products
* Known history of hypersensitivity to similar agents.
* Patients receiving any medications or substances that are inducers of CYP3A4 are ineligible: rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.