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.