ID

29809

Beskrivning

Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00956436

Länk

https://clinicaltrials.gov/show/NCT00956436

Nyckelord

  1. 2018-04-20 2018-04-20 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 april 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00956436

Eligibility Hepatocellular Carcinoma NCT00956436

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically-confirmed advanced hcc with at least 1 target lesion measurable by modified recist.
Beskrivning

Liver carcinoma Advanced | Target Lesion Measurable Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C1265611
child-pugh score a5 or a6.
Beskrivning

Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C2347612
ecog performance status of ≤2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system or brain metastases.
Beskrivning

CNS metastases | Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
prior anti-igf-1r therapy.
Beskrivning

Therapeutic procedure Against IGF1R

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C4044495
prior systemic therapy for advanced hcc. prior local therapies are only permitted if subjects have documented disease progression according to modified recist.
Beskrivning

Systemic therapy Liver carcinoma Advanced | Local Therapy Restricted Relationship Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0242656
concurrent anticancer therapy.
Beskrivning

Cancer treatment Concurrent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
history of myocardial infarction within 12 months prior to day 1 or chronic heart failure.
Beskrivning

Myocardial Infarction | Chronic heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0264716
acute hepatitis
Beskrivning

Hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019158
fibrolamellar hcc
Beskrivning

Fibrolamellar hepatocellular carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334287
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hepatocellular Carcinoma NCT00956436

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma Advanced | Target Lesion Measurable Quantity
Item
histologically-confirmed advanced hcc with at least 1 target lesion measurable by modified recist.
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Child-Pugh Classification
Item
child-pugh score a5 or a6.
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of ≤2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases | Metastatic malignant neoplasm to brain
Item
known central nervous system or brain metastases.
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Therapeutic procedure Against IGF1R
Item
prior anti-igf-1r therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C4044495 (UMLS CUI [1,3])
Systemic therapy Liver carcinoma Advanced | Local Therapy Restricted Relationship Disease Progression
Item
prior systemic therapy for advanced hcc. prior local therapies are only permitted if subjects have documented disease progression according to modified recist.
boolean
C1515119 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517925 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0242656 (UMLS CUI [2,4])
Cancer treatment Concurrent
Item
concurrent anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Myocardial Infarction | Chronic heart failure
Item
history of myocardial infarction within 12 months prior to day 1 or chronic heart failure.
boolean
C0027051 (UMLS CUI [1])
C0264716 (UMLS CUI [2])
Hepatitis
Item
acute hepatitis
boolean
C0019158 (UMLS CUI [1])
Fibrolamellar hepatocellular carcinoma
Item
fibrolamellar hcc
boolean
C0334287 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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