ID

29823

Description

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

Keywords

  1. 4/21/18 4/21/18 -
  2. 4/21/18 4/21/18 -
  3. 4/22/18 4/22/18 -
  4. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 22, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT01008358

Eligibility Hepatocellular Carcinoma NCT01008358

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal diagnosis of hcc
Description

Liver carcinoma

Data type

boolean

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

Disease unresectable | Disease Inappropriate Therapeutic procedure Locoregional

Data type

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
Description

Washout Period Post Sorafenib | Washout Period Post Pharmaceutical Preparations Systemic

Data type

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
Description

Washout Period Post Brachytherapy | Washout Period Post External Radiation

Data type

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
Description

Hepatitis C, Chronic

Data type

boolean

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

Child-Pugh Classification

Data type

boolean

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

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
ecog < 2
Description

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Liver function | Renal function | Hematologic function

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

CTL4 inhibitors

Data type

boolean

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

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

Data type

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
Description

Autoimmune Disease Treatment required for

Data type

boolean

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

Immunosuppressive Agents

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

Cancer Other | Exception Skin carcinoma | Exception Bladder Neoplasm Superficial

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
hiv infection
Description

HIV Infection

Data type

boolean

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

Heart Disease New York Heart Association Classification

Data type

boolean

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

Similar models

Eligibility Hepatocellular Carcinoma NCT01008358

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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