Age
Item
1. patients aged 18 to 65 years (19 to 65 years in korea) in phase i part or aged 18 to 75 years (19 to 75 years in korea) in phase ii part, either sex
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma
Item
2. patients diagnosed with hepatocellular carcinoma. the diagnosis of hcc (hepatocellular carcinoma) should be established by cytology or histopathology
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma | unresectable | Criteria Fulfill
Item
3. patients who have unresectable hcc and meet all of the following conditions:
boolean
C2239176 (UMLS CUI [1])
C1519810 (UMLS CUI [2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
BCLC Stage
Item
barcelona clinic liver cancer (bclc) stage b or c
boolean
C3899974 (UMLS CUI [1])
Transarterial Chemoembolization Unresponsive to Treatment | Transarterial Chemoembolization Inappropriate | Portal vein thrombosis
Item
transaarterial chemoembolization (tace) refractory in discretion of the investigators, or tace unsuitable (such as but not limited to portal vein thrombosis)
boolean
C3539919 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0155773 (UMLS CUI [3])
Local ablation therapy Inappropriate | Percutaneous ethanol injection | Radiofrequency ablation
Item
local ablative treatment (such as percutaneous ethanol injection, radiofrequency ablation, etc) unsuitable
boolean
C0547070 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1535909 (UMLS CUI [2])
C0850292 (UMLS CUI [3])
Sorafenib failed | Intolerance to Sorafenib | Sorafenib Ineligible
Item
sorafenib failure, intolerable or ineligible
boolean
C1516119 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C1516119 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
Measurable lesion linear Quantity | Lesion Appropriate Measurement Repeated
Item
4. 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
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C0205341 (UMLS CUI [2,4])
Child-Pugh Classification | Ascites Absent
Item
5. patients who have child-pugh's score no greater than 7, and have no ascites
boolean
C4050412 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patient Condition
Item
6. patients who have all the conditions below at screening:
boolean
C0030705 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
Alanine aminotransferase measurement
Item
serum alt (alanine aminotransferase) level (gpt) less than 2.5 x unl
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum ast (aspartate aminotransferase) level (got) less than 2.5 x unl
boolean
C0201899 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc (white blood cell) greater than or equal to 3,000 / microliter
boolean
C0023508 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine less than or equal to 1.5 x unl
boolean
C0201976 (UMLS CUI [1])
Activated Partial Thromboplastin Time measurement
Item
activated partial thromboplastin time (aptt) <1.5 x unl
boolean
C0030605 (UMLS CUI [1])
Platelet Count measurement
Item
7. platelet count correctable to greater than or equal to 80,000 / microliter
boolean
C0032181 (UMLS CUI [1])
Prothrombin time international normalized ratio (PT-INR)
Item
8. prothrombin time-international normalized ratio (pt-inr) correctable to less than 1.5
boolean
C1821762 (UMLS CUI [1])
Life Expectancy
Item
9. patients who have life expectancy longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Chemotherapy | Nitrosourea | Mitomycin
Item
1. patients who have had chemotherapy within last three weeks (6 weeks for nitrosourea or mitomycin-c) prior to dosing
boolean
C0392920 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0002475 (UMLS CUI [3])
Therapeutic radiology procedure Tumor site | Tumor growth subsequent
Item
2. 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
boolean
C1522449 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
C0598934 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
Investigational New Drugs | Antineoplastic Agents
Item
3. patients who have received other investigational or antineoplastic medication within the last four weeks prior to dosing
boolean
C0013230 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Bleeding esophageal varices
Item
4. patients who had history of esophageal variceal bleeding within eight weeks prior to study entry
boolean
C0155789 (UMLS CUI [1])
Diabetic - poor control | Communicable Disease | Chronic infectious disease | HIV Infection | Exception Bacterial colonisation Asymptomatic | Hepatitis B | Hepatitis C
Item
5. 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
boolean
C0421258 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C2747813 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Virus Disease
Item
6. patients who had acute viral infection syndrome diagnosed within the last two weeks
boolean
C0042769 (UMLS CUI [1])
Hematologic Neoplasms | Acute lymphocytic leukemia | Lymphoma, Non-Hodgkin
Item
7. patients who have concomitant hematological malignancy (e.g. acute lymphocytic leukemia, non-hodgkin's lymphoma)
boolean
C0376545 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
C0024305 (UMLS CUI [3])
Rheumatoid Arthritis | Autoimmune Diseases
Item
8. patients who have active rheumatoid arthritis or other autoimmune disease.
boolean
C0003873 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Patient need for Immunosuppressive Agents systemic chronic | Glucocorticoids Dose Any | Cyclosporine Dose Any | Glucocorticoids chronic | Cyclosporine chronic
Item
9. 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)
boolean
C0686904 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C0017710 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0010592 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
C0017710 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0010592 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Organ Transplantation | Therapeutic immunosuppression Prolonged Required
Item
10. patients with organ transplants (may require prolonged immunosuppressive therapy)
boolean
C0029216 (UMLS CUI [1])
C0021079 (UMLS CUI [2,1])
C0439590 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Study Subject Participation Status | Adenoviral Vector
Item
11. patients who had prior participation in any research protocol which involved administration of adenovirus vectors
boolean
C2348568 (UMLS CUI [1])
C1510800 (UMLS CUI [2])
Blood product Immune system Related | Immunoglobulins
Item
12. patients received any immune-related related related related related blood products, such as immunoglobulin in the prior 3 months
boolean
C0456388 (UMLS CUI [1,1])
C0020962 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0021027 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
13. 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
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Mental disorders compromise Informed Consent | Addictive Behavior compromises Informed Consent | Disease compromises Informed Consent | Mental disorders compromise Compliance behavior | Addictive Behavior compromises Compliance behavior | Disease compromises Compliance behavior
Item
14. psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
boolean
C0004936 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C0085281 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1321605 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
15. female patients that are pregnant or on breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antiplatelet Agents | Anticoagulants | heparin | Warfarin | Aspirin | Ticlopidine | clopidogrel | Dipyridamole
Item
16. patients who receive anti-platelet agents or anti-coagulation agents (e.g. heparin, warfarin, aspirin, ticlopidine, clopidogrel, dipyridamole and so on).
boolean
C0085826 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
C0004057 (UMLS CUI [5])
C0040207 (UMLS CUI [6])
C0070166 (UMLS CUI [7])
C0012582 (UMLS CUI [8])