Liver carcinoma | Disease unresectable | Prior Therapy Sorafenib | Sorafenib Rejected | Sorafenib Unavailable
Item
for parts 1 and 2, confirmed diagnosis of hcc by histological examination or by non-invasive criteria according to (european association for the study of the liver (easl) or american association for the study of liver disease (aasld) guidelines. patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
boolean
C2239176 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C1516119 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
C1516119 (UMLS CUI [5,1])
C0686905 (UMLS CUI [5,2])
Cholangiocarcinoma | Disease unresectable
Item
or for part 2: confirmed diagnosis of cholangiocarcinoma with unresectable disease
boolean
C0206698 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Child-Pugh Classification | Ascites Absent
Item
child-pugh class a with no clinically apparent ascites
boolean
C2347612 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Tumor tissue sample | Tumor Biopsy Pretreatment
Item
willing to provide archived tumor tissue (if available) and willing to undergo pre-
boolean
C0475358 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C3539076 (UMLS CUI [2,3])
Tumor Biopsy During Therapeutic procedure
Item
and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
CNS metastases
Item
central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count <75,000/ml
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count <1000/ml
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <8 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5x the upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin >2.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
International Normalized Ratio | Prothrombin time test
Item
international normalized ratio (inr) >2.3 or prothrombin time (pt) >6 seconds above control
boolean
C0525032 (UMLS CUI [1])
C0491338 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
estimated (cockroft-gault formula) or measured creatinine clearance <40 ml/min
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])