Age
Item
male or female age >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >/= 12 weeks
boolean
C0023671 (UMLS CUI [1])
Liver cell carcinoma non-resectable Advanced | Metastatic hepatocellular carcinoma
Item
histologically or cytologically confirmed diagnosis of hcc, unresectable advanced or metastatic
boolean
C1112459 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0744869 (UMLS CUI [2])
Liver function Clinical findings Child-Pugh Classification | Liver function Laboratory Results Child-Pugh Classification
Item
liver function status of child-pugh class a. child-pugh status based on clinical findings and laboratory results during the screening period
boolean
C0232741 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C1254595 (UMLS CUI [2,2])
C2347612 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Linear Quantity | CT | MRI | Therapy naive Locoregional
Item
patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by ct or mri according to recist 1.1
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0919936 (UMLS CUI [4,1])
C1947913 (UMLS CUI [4,2])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Malignant Neoplasms | Exception Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder
Item
previous or concurrent cancer other than hcc, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
Heart Disease | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Uncontrolled hypertension
Item
history of cardiac disease: congestive heart failure (chf), unstable angina, arrhythmias, uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
Gastrointestinal Hemorrhage CTCAE Grades
Item
clinically significant gi bleeding (ctcae grade 3 or higher) within 30 days
boolean
C0017181 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis
Item
renal failure requiring hemo- or peritoneal dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0031139 (UMLS CUI [2,3])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic
Item
known history or symptomatic metastatic brain or meningeal tumors
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1704231 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Organ Allograft
Item
history of organ allograft.
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Lung Disease, Interstitial
Item
history of interstitial lung disease (ild).
boolean
C0206062 (UMLS CUI [1])
Prior Therapy Excluded | Pharmaceutical Preparations Excluded
Item
excluded previous therapies and medications:
boolean
C1514463 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Cancer treatment Systemic Liver carcinoma | Cytotoxic Chemotherapy | Pharmaceutical Preparations Targeted | Therapy, Investigational
Item
prior use of systemic anti-cancer treatment for hcc including cytotoxic chemotherapy, targeted agents, or any experimental therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4])
Therapeutic radiology procedure
Item
radiotherapy within 4 weeks prior to start of study treatment
boolean
C1522449 (UMLS CUI [1])
Investigational New Drugs
Item
any other investigational agents within 4 weeks from the first dose of study treatment
boolean
C0013230 (UMLS CUI [1])
Major surgery
Item
major surgery within 4 weeks of start of study
boolean
C0679637 (UMLS CUI [1])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
concomitant use of strong inhibitors and strong inducers of cyp3a4
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])