Age | Liver carcinoma Advanced
Item
subjects of 18 years or older (men and women) with histological confirmation of advanced hepatocellular carcinoma
boolean
C0001779 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Dose Escalation Cohort | Infection Absent | Hepatitis C | Hepatitis B | Progressive Disease | Intolerance Systemic therapy Quantity | Sorafenib Refused
Item
for the dose escalation cohorts (uninfected, hcv-infected, and hbv-infected): subjects must have progressive disease following or be intolerant of at least one line of systemic therapy or refuse sorafenib treatment
boolean
C3816728 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C3714514 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
C0231199 (UMLS CUI [6,1])
C1515119 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1516119 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Infection Absent | Sorafenib Absent | Intolerance to Sorafenib | Liver carcinoma Expansion
Item
for the uninfected sorafenib naive or intolerant hcc expansion cohort, subjects must either never have received sorafenib treatment or were intolerant to sorafenib therapy
boolean
C3714514 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C1519678 (UMLS CUI [4,2])
Infection Absent | Sorafenib failed | Liver carcinoma Expansion | Disease Progression Radiography | Disease Progression Symptomatic
Item
for the uninfected sorafenib failure hcc expansion cohort, subjects must have had documented radiographic or symptomatic progression during or after sorafenib therapy
boolean
C3714514 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C1519678 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
Dose Escalation Phase | Child-Pugh Score | Child-Pugh Classification
Item
dose escalation phase: child-pugh score of 7 points or less, i.e., child-pugh a or child pugh b7
boolean
C3816728 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C4055253 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Expansion Phase | Child-Pugh Score | Child-Pugh Classification
Item
expansion phase: child-pugh score of 6 points or less, i.e., child-pugh a
boolean
C1519678 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C4055253 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
subjects with brain metasteses
boolean
C0220650 (UMLS CUI [1])
Ascites Physical Examination | Paracentesis Required
Item
any prior or current clinically significant ascites as measured by physical examination and that requires active parancentesis for control
boolean
C0003962 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0034115 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Bleeding varices
Item
any history of clinically meaningful variceal bleeding within the last three months
boolean
C0333106 (UMLS CUI [1])
HBV coinfection | HCV coinfection
Item
active coinfection with both hepatitis b and c
boolean
C2242656 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
Hepatitis D Infection In addition to Hepatitis B
Item
hepatitis d infection in subjects with hepatitis b
boolean
C0011226 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])