Ensayos clínicos

Inclusion Criteria:

• Histologically or cytologically confirmed hepatocellular carcinoma that is refractory to or intolerant of sorafenib based therapy
• Absolute neutrophil count (ANC) ≥ 1000/mm^3
• Platelet count ≥ 80,000/mm^3
• Hemoglobin ≥ 10 g/dl
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) &l; 5 times upper limit of normal
• Creatinine within institutional limits of normal
• Total bilirubin ≤ 3 x upper limit of normal (ULN)
• International normalized ratio (INR) ≤ 1.4 x ULN
• Activated partial thromboplastin time (aPTT) within institutional limits of normal
• Ability to provide informed written consent
• Willingness to return to Mayo Clinic in Arizona for follow-up
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Willingness to provide all biological specimens as required by the protocol
• Negative serum pregnancy test ≤ 7 days prior to registration for women of childbearing potential only
• Child Pugh Score A or B7
• The patient and their partner agree to use a barrier method of contraception during the study and 4 months following end of active treatment

Exclusion Criteria:

• Uncontrolled infection
• Systemic anti-cancer therapy ≤ 4 weeks prior to registration
• Known human immunodeficiency virus (HIV) infection
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy
• Pregnant or nursing women
• History of bone marrow or solid organ transplantation
• Patient for whom surgical resection or liver transplantation would be more appropriate
• Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study