Age | systemic therapy Quantity Advanced Adult Hepatocellular Carcinoma | systemic therapy Quantity Metastatic hepatocellular carcinoma
Item
patients >18 years affected by advanced or metastatic hcc previously treated with no more than one systemic therapeutic regimen
boolean
C0001779 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1706732 (UMLS CUI [2,3])
C1515119 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0744869 (UMLS CUI [3,3])
Liver carcinoma Curative Surgery Amenable
Item
histologically confirmed hcc not amenable to curative surgery
boolean
C2239176 (UMLS CUI [1,1])
C1511562 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
Child-Pugh Classification
Item
child-pugh scale class a
boolean
C4050412 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Disease Progression X-Ray Computed Tomography
Item
patients in progression disease at study entry ct documented
boolean
C0242656 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
adequate baseline bone marrow, hepatic and renal function, defined as follows:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophils > 1.5 x 10^9/l and platelets > 100 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 2 x uln
boolean
C1278039 (UMLS CUI [1])
Transaminases
Item
transaminases < 3 x uln
boolean
C0002594 (UMLS CUI [1])
Fluid overload | Increased cardiac stroke volume | Increase in blood pressure | Hemodilution | Patient Risk Absent
Item
absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin")
boolean
C0546817 (UMLS CUI [1])
C0520872 (UMLS CUI [2])
C0497247 (UMLS CUI [3])
C0019009 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Cardiac function | Uncontrolled hypertension Absent
Item
normal cardiac function and absence of uncontrolled hypertension
boolean
C0232164 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
patients must give written informed consent
boolean
C0021430 (UMLS CUI [1])
Decompensated cirrhosis Child-Pugh Classification
Item
decompensated cirrhosis (child-pugh score >7)
boolean
C1619727 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
cancer treatment
Item
concurrent anticancer therapy
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not receive any other investigational agents while on study
boolean
C0013230 (UMLS CUI [1])
Central Nervous System Involvement Sign or Symptom
Item
clinical signs of cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Inconsistent Study Protocol
Item
patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0442809 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Hypersensitivity Human Albumin | Hypersensitivity Human Albumin Excipient | Allergic Reaction Human Albumin | Allergic Reaction Human Albumin Excipient
Item
known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304925 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0304925 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Mental condition Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
boolean
C3840291 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Postmenopausal state | Sexual sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0038288 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])