Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients aged 18 to 65 years (19 to 65 years in Korea), either sex
Patients diagnosed with hepatocellular carcinoma. The diagnosis of HCC (hepatocellular carcinoma) should be established by cytology or histopathology

Patients who have unresectable HCC and meet all of the following conditions:

Barcelona Clinic Liver Cancer (BCLC) stage B or C
TransAarterial ChemoEmbolization (TACE) refractory in discretion of the investigators, or TACE unsuitable (such as but not limited to portal vein thrombosis)
Local ablative treatment (such as percutaneous ethanol injection, radiofrequency ablation, etc) unsuitable
Sorafenib failure, intolerable or ineligible
Patients must have at least one lesion that can be accurately measured in at least one dimension as 1 cm or more and the lesion must be suitable for repeat measurement
Patients who have Child-Pugh's Score no greater than 7, and have no ascites

Patients who have all the conditions below at screening:

serum ALT (Alanine Aminotransferase) level (GPT) less than 2.5 x UNL

serum AST (Aspartate Aminotransferase) level (GOT) less than 2.5 x UNL
WBC (white blood cell) greater than or equal to 3,000 / microliter
Serum creatinine less than or equal to 1.5 x UNL
activated partial thromboplastin time (APTT) <1.5 x UNL
Platelet count correctable to greater than or equal to 80,000 / microliter
prothrombin time-international normalized ratio (PT-INR) correctable to less than 1.5
Patients who have life expectancy longer than 12 weeks

Exclusion Criteria:

Patients who have had chemotherapy within last three weeks (6 weeks for nitrosourea or Mitomycin-C) prior to dosing
Patients who have had radiotherapy to tumor site within the last four weeks prior to dosing and with documentation of subsequent tumor growth at this site
Patients who have received other investigational or antineoplastic medication within the last four weeks prior to dosing
Patients who had history of esophageal variceal bleeding within eight weeks prior to study entry
Patients who have uncontrolled diabetes, active or chronic infection, including HIV, except for asymptomatic bacterial colonization, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Patients who had acute viral infection syndrome diagnosed within the last two weeks
Patients who have concomitant hematological malignancy (e.g. acute lymphocytic leukemia, non-Hodgkin's lymphoma)
Patients who have active rheumatoid arthritis or other autoimmune disease.
Patients who have current requirement for chronic systemic immunosuppressive medication including any dose of glucocorticoid or cyclosporin, or chronic use of any such medication within the last four weeks Note: Course of glucocorticoid therapy less than 10 days duration is allowed (e.g. for nausea control)
Patients with organ transplants (may require prolonged immunosuppressive therapy)
Patients who had prior participation in any research protocol which involved administration of adenovirus vectors
Patients received any immune-related related related related related blood products, such as immunoglobulin in the prior 3 months
Patients who have uncontrolled concurrent 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
Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
Female patients that are pregnant or on breast-feeding
Patients who receive anti-platelet agents or anti-coagulation agents (e.g. Heparin, warfarin, aspirin, ticlopidine, clopidogrel, dipyridamole and so on).