ID

29823

Beschrijving

Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01008358

Link

https://clinicaltrials.gov/show/NCT01008358

Trefwoorden

Versies (4)
  1. 21-04-18 21-04-18 -
  2. 21-04-18 21-04-18 -
  3. 22-04-18 22-04-18 -
  4. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01008358

Engels

Eligibility Hepatocellular Carcinoma NCT01008358

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal diagnosis of hcc
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
unresectable disease not amenable to locoregional treatment.
Beschrijving

Disease unresectable | Disease Inappropriate Therapeutic procedure Locoregional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1947913
a 4-week washout period after sorafenib or any other systemic agent
Beschrijving

Washout Period Post Sorafenib | Washout Period Post Pharmaceutical Preparations Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1516119
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C0205373
a 2-month washout period after internal or external radiation
Beschrijving

Washout Period Post Brachytherapy | Washout Period Post External Radiation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0006098
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1517033
hcv chronic infection
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
child-pugh stage a or b
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
measurable disease according to recist criteria
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
ecog < 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
expected survival > 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
adequate liver, renal and blood functions
Beschrijving

Liver function | Renal function | Hematologic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
ability to sign informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an anti-ctl-4 agent
Beschrijving

CTL4 inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C3711064
UMLS CUI [1,2]
C0243077
serious infections or disease compromising general health status
Beschrijving

Communicable Disease Serious compromises General health | Disease Serious compromises General health

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0424575
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0424575
autoimmune disease that requires therapy
Beschrijving

Autoimmune Disease Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332121
treatment with immunosuppressors
Beschrijving

Immunosuppressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0021081
treatment with investigational agents
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
other neoplasms except skin and bladder superficial tumors
Beschrijving

Cancer Other | Exception Skin carcinoma | Exception Bladder Neoplasm Superficial

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005695
UMLS CUI [3,3]
C0205124
pregnancy or lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
snc metastasis
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
hiv infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
relevant heart disease (nyha class iii or iv)
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Hepatocellular Carcinoma NCT01008358

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
unequivocal diagnosis of hcc
boolean
C2239176 (UMLS CUI [1])
Disease unresectable | Disease Inappropriate Therapeutic procedure Locoregional
Item
unresectable disease not amenable to locoregional treatment.
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1947913 (UMLS CUI [2,4])
Washout Period Post Sorafenib | Washout Period Post Pharmaceutical Preparations Systemic
Item
a 4-week washout period after sorafenib or any other systemic agent
boolean
C1710661 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Washout Period Post Brachytherapy | Washout Period Post External Radiation
Item
a 2-month washout period after internal or external radiation
boolean
C1710661 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0006098 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1517033 (UMLS CUI [2,3])
Hepatitis C, Chronic
Item
hcv chronic infection
boolean
C0524910 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh stage a or b
boolean
C2347612 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog < 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected survival > 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function | Hematologic function
Item
adequate liver, renal and blood functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Informed Consent
Item
ability to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CTL4 inhibitors
Item
previous treatment with an anti-ctl-4 agent
boolean
C3711064 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
Communicable Disease Serious compromises General health | Disease Serious compromises General health
Item
serious infections or disease compromising general health status
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0424575 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0424575 (UMLS CUI [2,4])
Autoimmune Disease Treatment required for
Item
autoimmune disease that requires therapy
boolean
C0004364 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Immunosuppressive Agents
Item
treatment with immunosuppressors
boolean
C0021081 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with investigational agents
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Bladder Neoplasm Superficial
Item
other neoplasms except skin and bladder superficial tumors
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005695 (UMLS CUI [3,2])
C0205124 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CNS metastases
Item
snc metastasis
boolean
C0686377 (UMLS CUI [1])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
relevant heart disease (nyha class iii or iv)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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