ID

44492

Beskrivning

Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib; ODM derived from: https://clinicaltrials.gov/show/NCT01352728

Länk

https://clinicaltrials.gov/show/NCT01352728

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01352728

Engelsk

Eligibility Hepatocellular Carcinoma NCT01352728

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed hcc (or fulfilling aasld criteria for hcc diagnosis in hbsag positive subjects with cirrhosis in case biopsy is not feasible)
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
2. disease must not be amenable to potentially curative surgery
Beskrivning

Disease Inappropriate Curative Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1511562
3. without prior systemic nor transarterial treatment
Beskrivning

Systemic therapy Absent | Therapy Arterial Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0221464
UMLS CUI [2,3]
C0332197
4. prior surgery or local therapy is allowed but the target lesion must have not been previously treated
Beskrivning

Operative Surgical Procedures | Local Therapy | Target Lesion untreated

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1517925
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0332155
5. child-pugh stage a liver function
Beskrivning

Liver function Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
6. ecog performance 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. life expectancy longer than 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. at least one measurable treatment lesion according to modified recist criteria
Beskrivning

Therapy Measurable lesion Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1265611
9. adequate haematological, hepatic and renal function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. contra-indications to tace treatment:
Beskrivning

Medical contraindication Transarterial Chemoembolization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3539919
main portal vein thrombosis or occlusion
Beskrivning

Main portal vein Thrombosis | Main portal vein Occlusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C0040053
UMLS CUI [2,1]
C1183135
UMLS CUI [2,2]
C0028778
evidence of biliary obstruction
Beskrivning

Obstruction of biliary tree

Datatyp

boolean

Alias
UMLS CUI [1]
C0400979
presence of extra-hepatic disease
Beskrivning

Disease Extrahepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
2. diffuse-type hcc
Beskrivning

Liver carcinoma Type Diffuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0205219
3. 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
4. any form of prior transarterial therapy or systemic therapy for hcc.
Beskrivning

Therapy Arterial Liver carcinoma | Systemic therapy Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221464
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C2239176
5. current use or anticipated need for treatment with drugs that are known potent cyp3a4 inhibitors or cyp3a4 or cyp1a2 inducers.
Beskrivning

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong | CYP1A2 Inducers Strong | Patient need for CYP3A4 Inhibitors Strong | Patient need for CYP3A4 Inducers Strong | Patient need for CYP1A2 Inducers Strong

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3850050
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C3850053
UMLS CUI [4,3]
C0442821
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C3850041
UMLS CUI [5,3]
C0442821
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C3850050
UMLS CUI [6,3]
C0442821
6. requirement of anticoagulant therapy with oral vitamin k antagonists. low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. therapeutic use of low molecular weight heparin is allowed.
Beskrivning

Requirement Anticoagulant therapy | Requirement Vitamin K antagonists Oral | Low Molecular Weight Heparin allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3653316
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C0019139
UMLS CUI [3,2]
C0683607
7. any haemorrhage or bleeding event of ctcae grade 3 or more within 4 week
Beskrivning

Hemorrhage CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Hepatocellular Carcinoma NCT01352728

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
1. histologically confirmed hcc (or fulfilling aasld criteria for hcc diagnosis in hbsag positive subjects with cirrhosis in case biopsy is not feasible)
boolean
C2239176 (UMLS CUI [1])
Disease Inappropriate Curative Surgery
Item
2. disease must not be amenable to potentially curative surgery
boolean
C0012634 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
Systemic therapy Absent | Therapy Arterial Absent
Item
3. without prior systemic nor transarterial treatment
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0221464 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Operative Surgical Procedures | Local Therapy | Target Lesion untreated
Item
4. prior surgery or local therapy is allowed but the target lesion must have not been previously treated
boolean
C0543467 (UMLS CUI [1])
C1517925 (UMLS CUI [2])
C2986546 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Liver function Child-Pugh Classification
Item
5. child-pugh stage a liver function
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
ECOG performance status
Item
6. ecog performance 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Therapy Measurable lesion Quantity
Item
8. at least one measurable treatment lesion according to modified recist criteria
boolean
C0087111 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hematologic function | Liver function | Renal function
Item
9. adequate haematological, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Transarterial Chemoembolization
Item
1. contra-indications to tace treatment:
boolean
C1301624 (UMLS CUI [1,1])
C3539919 (UMLS CUI [1,2])
Main portal vein Thrombosis | Main portal vein Occlusion
Item
main portal vein thrombosis or occlusion
boolean
C1183135 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C1183135 (UMLS CUI [2,1])
C0028778 (UMLS CUI [2,2])
Obstruction of biliary tree
Item
evidence of biliary obstruction
boolean
C0400979 (UMLS CUI [1])
Disease Extrahepatic
Item
presence of extra-hepatic disease
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Liver carcinoma Type Diffuse
Item
2. diffuse-type hcc
boolean
C2239176 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,3])
Major surgery | Therapeutic radiology procedure
Item
3. major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Therapy Arterial Liver carcinoma | Systemic therapy Liver carcinoma
Item
4. any form of prior transarterial therapy or systemic therapy for hcc.
boolean
C0087111 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong | CYP1A2 Inducers Strong | Patient need for CYP3A4 Inhibitors Strong | Patient need for CYP3A4 Inducers Strong | Patient need for CYP1A2 Inducers Strong
Item
5. current use or anticipated need for treatment with drugs that are known potent cyp3a4 inhibitors or cyp3a4 or cyp1a2 inducers.
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3850050 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C3850053 (UMLS CUI [4,2])
C0442821 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C3850041 (UMLS CUI [5,2])
C0442821 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C3850050 (UMLS CUI [6,2])
C0442821 (UMLS CUI [6,3])
Requirement Anticoagulant therapy | Requirement Vitamin K antagonists Oral | Low Molecular Weight Heparin allowed
Item
6. requirement of anticoagulant therapy with oral vitamin k antagonists. low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. therapeutic use of low molecular weight heparin is allowed.
boolean
C1514873 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3653316 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0019139 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Hemorrhage CTCAE Grades
Item
7. any haemorrhage or bleeding event of ctcae grade 3 or more within 4 week
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Tillbaka till toppen 

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