ID

39770

Beskrivning

Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01334112

Länk

https://clinicaltrials.gov/show/NCT01334112

Nyckelord

Versioner (2)
  1. 2020-02-18 2020-02-18 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01334112

Engelsk

Eligibility Hepatocellular Carcinoma NCT01334112

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
unresectable and/or metastatic hepatocellular carcinoma
Beskrivning

Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1112459
UMLS CUI [2]
C0744869
previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
Beskrivning

Prior Therapy | Tyrosine kinase inhibitor | Angiogenesis Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1268567
UMLS CUI [3]
C0596087
life expectancy of ≥12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
at least one tumor lesion
Beskrivning

Tumor Lesion Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1265611
at least 2 weeks since the end of prior systemic treatment
Beskrivning

Systemic therapy Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205156
no evidence of pre-existing uncontrolled hypertension
Beskrivning

Absence Uncontrolled hypertension Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1868885
UMLS CUI [1,3]
C2347662
ecog 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
not appropriate for curative therapy
Beskrivning

Patient Inappropriate Curative treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1273390
child a or b7 cirrhosis
Beskrivning

Liver Cirrhosis Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2347612
clip score ≤ 4
Beskrivning

Liver carcinoma Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0449820
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received any other systemic therapy for hepatocellular carcinoma within 2 weeks prior to treatment
Beskrivning

Systemic therapy Other Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2239176
major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
Beskrivning

Major surgery | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
previous or concurrent cancer that is distinct in primary site or histology from hepatocellular carcinoma
Beskrivning

Cancer Other | Primary site Except Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0449695
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2239176
severe acute or chronic medical or psychiatric condition
Beskrivning

Medical condition Severe | Chronic disease Severe | Mental Disorders, Severe | Chronic mental disorder Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C4046029
UMLS CUI [4,1]
C0870281
UMLS CUI [4,2]
C0205082
need for treatment with prohibited drugs
Beskrivning

Patient need for Illicit Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0086190
has received local therapy to all measurable lesions
Beskrivning

Local Therapy Measurable lesion All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0444868
stage b8 or higher liver cirrhosis
Beskrivning

Liver Cirrhosis Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2347612
ascites refractory to diuretic therapy
Beskrivning

Ascites Unresponsive to Diuretic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0948575
clinically significant ecg abnormality
Beskrivning

Electrocardiogram abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
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Similar models

Eligibility Hepatocellular Carcinoma NCT01334112

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma
Item
unresectable and/or metastatic hepatocellular carcinoma
boolean
C1112459 (UMLS CUI [1])
C0744869 (UMLS CUI [2])
Prior Therapy | Tyrosine kinase inhibitor | Angiogenesis Inhibitors
Item
previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
boolean
C1514463 (UMLS CUI [1])
C1268567 (UMLS CUI [2])
C0596087 (UMLS CUI [3])
Life Expectancy
Item
life expectancy of ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Tumor Lesion Quantity
Item
at least one tumor lesion
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Systemic therapy Previous
Item
at least 2 weeks since the end of prior systemic treatment
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Absence Uncontrolled hypertension Pre-existing
Item
no evidence of pre-existing uncontrolled hypertension
boolean
C0332197 (UMLS CUI [1,1])
C1868885 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
ECOG performance status
Item
ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Patient Inappropriate Curative treatment
Item
not appropriate for curative therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
Liver Cirrhosis Child-Pugh Classification
Item
child a or b7 cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Liver carcinoma Score
Item
clip score ≤ 4
boolean
C2239176 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Other Liver carcinoma
Item
received any other systemic therapy for hepatocellular carcinoma within 2 weeks prior to treatment
boolean
C1515119 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
Major surgery | Therapeutic radiology procedure
Item
major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Cancer Other | Primary site Except Liver carcinoma
Item
previous or concurrent cancer that is distinct in primary site or histology from hepatocellular carcinoma
boolean
C1707251 (UMLS CUI [1])
C0449695 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Medical condition Severe | Chronic disease Severe | Mental Disorders, Severe | Chronic mental disorder Severe
Item
severe acute or chronic medical or psychiatric condition
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4046029 (UMLS CUI [3])
C0870281 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Patient need for Illicit Drugs
Item
need for treatment with prohibited drugs
boolean
C0686904 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Local Therapy Measurable lesion All
Item
has received local therapy to all measurable lesions
boolean
C1517925 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Liver Cirrhosis Child-Pugh Classification
Item
stage b8 or higher liver cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Ascites Unresponsive to Diuretic therapy
Item
ascites refractory to diuretic therapy
boolean
C0003962 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0948575 (UMLS CUI [1,3])
Electrocardiogram abnormal
Item
clinically significant ecg abnormality
boolean
C0522055 (UMLS CUI [1])
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