ID

44485

Beschrijving

E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01271504

Link

https://clinicaltrials.gov/show/NCT01271504

Trefwoorden

Versies (2)
  1. 18-02-20 18-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01271504

Engels

Eligibility Hepatocellular Carcinoma NCT01271504

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
unresectable locally advanced or metastatic hcc;
Beschrijving

Liver cell carcinoma non-resectable Advanced Locally | Liver cell carcinoma non-resectable metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1112459
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1112459
UMLS CUI [2,2]
C1522484
histologic confirmation not required if other diagnostic criteria are met;
Beschrijving

Diagnostic criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C1550543
no previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in phase ib). previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if >6 weeks of first day of study-defined treatment;
Beschrijving

Cancer treatment Systemic Absent | Chemoembolization | Radioembolisation | Radiofrequency ablation | Local ablative therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0796679
UMLS CUI [3]
C2985560
UMLS CUI [4]
C0850292
UMLS CUI [5]
C0547070
ecog ps 0 or 1; child-pugh cirrhotic status a or b with a score of 7;
Beschrijving

ECOG performance status | Status Cirrhotic Child-Pugh Classification | Status Cirrhotic Child-Pugh - Total Score

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0439686
UMLS CUI [2,3]
C4050412
UMLS CUI [3,1]
C0449438
UMLS CUI [3,2]
C0439686
UMLS CUI [3,3]
C4055253
blood pressure must be well-controlled (less than or equal to 140/90 mmhg at screening) with or without antihypertensive medication. patients must have no history of hypertensive crisis or hypertensive encephalopathy;
Beschrijving

Blood Pressure Well controlled | Blood pressure determination | Antihypertensive Agents | Antihypertensive Agents Absent | Hypertensive crisis Absent | Hypertensive Encephalopathy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853142
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0003364
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0020546
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0151620
UMLS CUI [6,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously received e7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in phase ib only);
Beschrijving

c-Met/VEGFR-2 Kinase Inhibitor E7050 | Antiangiogenic therapy

Datatype

boolean

Alias
UMLS CUI [1]
C2830057
UMLS CUI [2]
C2363719
presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
Beschrijving

Metastatic malignant neoplasm to brain | Exception Therapy Adequate | Exception Stable status Asymptomatic | Exception Steroids Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0231221
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C0332197
palliative radiotherapy is not permitted throughout the study period;
Beschrijving

Palliative course of radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0475092
active hemoptysis
Beschrijving

Hemoptysis

Datatype

boolean

Alias
UMLS CUI [1]
C0019079
serious non-healing wound, ulcer, or active bone fracture;
Beschrijving

Non healing wound Serious | Ulcer | Bone fracture

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
Beschrijving

Major surgery | Incisional biopsy | Traumatic injury | Patient need for Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0679637
clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (tips) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.
Beschrijving

Gastrointestinal Hemorrhage | Hemorrhage Requirement Intervention | Variceal Banding | Transjugular intrahepatic portosystemic shunt procedure | Transarterial embolization | Coagulation therapy Topical

Datatype

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
UMLS CUI [3]
C4288030
UMLS CUI [4]
C0339897
UMLS CUI [5]
C3163695
UMLS CUI [6,1]
C0441509
UMLS CUI [6,2]
C1522168
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Similar models

Eligibility Hepatocellular Carcinoma NCT01271504

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver cell carcinoma non-resectable Advanced Locally | Liver cell carcinoma non-resectable metastatic
Item
unresectable locally advanced or metastatic hcc;
boolean
C1112459 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1112459 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Diagnostic criteria Fulfill
Item
histologic confirmation not required if other diagnostic criteria are met;
boolean
C0679228 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Cancer treatment Systemic Absent | Chemoembolization | Radioembolisation | Radiofrequency ablation | Local ablative therapy
Item
no previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in phase ib). previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if >6 weeks of first day of study-defined treatment;
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0796679 (UMLS CUI [2])
C2985560 (UMLS CUI [3])
C0850292 (UMLS CUI [4])
C0547070 (UMLS CUI [5])
ECOG performance status | Status Cirrhotic Child-Pugh Classification | Status Cirrhotic Child-Pugh - Total Score
Item
ecog ps 0 or 1; child-pugh cirrhotic status a or b with a score of 7;
boolean
C1520224 (UMLS CUI [1])
C0449438 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
C0449438 (UMLS CUI [3,1])
C0439686 (UMLS CUI [3,2])
C4055253 (UMLS CUI [3,3])
Blood Pressure Well controlled | Blood pressure determination | Antihypertensive Agents | Antihypertensive Agents Absent | Hypertensive crisis Absent | Hypertensive Encephalopathy Absent
Item
blood pressure must be well-controlled (less than or equal to 140/90 mmhg at screening) with or without antihypertensive medication. patients must have no history of hypertensive crisis or hypertensive encephalopathy;
boolean
C0005823 (UMLS CUI [1,1])
C3853142 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0020546 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0151620 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
c-Met/VEGFR-2 Kinase Inhibitor E7050 | Antiangiogenic therapy
Item
previously received e7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in phase ib only);
boolean
C2830057 (UMLS CUI [1])
C2363719 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Exception Therapy Adequate | Exception Stable status Asymptomatic | Exception Steroids Absent
Item
presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Palliative course of radiotherapy
Item
palliative radiotherapy is not permitted throughout the study period;
boolean
C0475092 (UMLS CUI [1])
Hemoptysis
Item
active hemoptysis
boolean
C0019079 (UMLS CUI [1])
Non healing wound Serious | Ulcer | Bone fracture
Item
serious non-healing wound, ulcer, or active bone fracture;
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Major surgery | Incisional biopsy | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0679637 (UMLS CUI [4,2])
Gastrointestinal Hemorrhage | Hemorrhage Requirement Intervention | Variceal Banding | Transjugular intrahepatic portosystemic shunt procedure | Transarterial embolization | Coagulation therapy Topical
Item
clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (tips) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.
boolean
C0017181 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C4288030 (UMLS CUI [3])
C0339897 (UMLS CUI [4])
C3163695 (UMLS CUI [5])
C0441509 (UMLS CUI [6,1])
C1522168 (UMLS CUI [6,2])
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