ID

44485

Beschreibung

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

Stichworte

Versionen (2)
  1. 18.02.20 18.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hepatocellular Carcinoma NCT01271504

Englisch

Eligibility Hepatocellular Carcinoma NCT01271504

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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;
Beschreibung

Diagnostic criteria Fulfill

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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
Beschreibung

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);
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Palliative course of radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0475092
active hemoptysis
Beschreibung

Hemoptysis

Datentyp

boolean

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

Non healing wound Serious | Ulcer | Bone fracture

Datentyp

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;
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01271504

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video