ID

40921

Description

A Study of IMC-A12 in Combination With Sorafenib in Patients With Advanced Cancer of the Liver; ODM derived from: https://clinicaltrials.gov/show/NCT00906373

Link

https://clinicaltrials.gov/show/NCT00906373

Keywords

Versions (1)
  1. 6/5/20 6/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00906373

English

Eligibility Hepatocellular Carcinoma NCT00906373

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient has histologically or cytologically confirmed, unresectable hcc
Description

Liver cell carcinoma non-resectable

Data type

boolean

Alias
UMLS CUI [1]
C1112459
the patient has at least one target lesion measurable according to response evaluation criteria in solid tumors (recist) guidelines. target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. if a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
Description

Target Lesion Measurable Quantity | Target Lesion Therapeutic radiology procedure Absent | Target Lesion Ablation Absent | Target Lesion Chemoembolization Absent | Tumor growth | Tumor hypervascular

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0547070
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C2986546
UMLS CUI [4,2]
C0796679
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0598934
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C1512560
the patient has not received prior systemic therapy for hcc. patients may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
Description

Systemic therapy Absent Liver carcinoma | Embolization | Chemoembolization | Chemotherapy by intra-arterial infusion | Ethanol Injection | Radiofrequency ablation | Cryosurgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2239176
UMLS CUI [2]
C0013931
UMLS CUI [3]
C0796679
UMLS CUI [4]
C2045832
UMLS CUI [5]
C4307245
UMLS CUI [6]
C0850292
UMLS CUI [7]
C0010408
the patient has fasting serum glucose < 160 mg/dl or below the uln and/or hemoglobin a1c < 7%. if baseline nonfasting glucose < 160 mg/dl, fasting glucose measurement is not required
Description

Serum fasting glucose measurement | Hemoglobin A1c measurement | Glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583334
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0337438
the patient has the ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
the patient has acute hepatitis
Description

Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019158
the patient has poorly controlled diabetes mellitus. patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
Description

Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
the patient has congestive heart failure > class ii nyha, unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
Description

Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340289
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0085612
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0003195
the patient has experienced a hemorrhage or bleeding event ≥ nci-ctcae grade 3 within 4 weeks prior first dose of study therapy
Description

Hemorrhage CTCAE Grades

Data type

boolean

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

Eligibility Hepatocellular Carcinoma NCT00906373

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver cell carcinoma non-resectable
Item
the patient has histologically or cytologically confirmed, unresectable hcc
boolean
C1112459 (UMLS CUI [1])
Target Lesion Measurable Quantity | Target Lesion Therapeutic radiology procedure Absent | Target Lesion Ablation Absent | Target Lesion Chemoembolization Absent | Tumor growth | Tumor hypervascular
Item
the patient has at least one target lesion measurable according to response evaluation criteria in solid tumors (recist) guidelines. target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. if a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C0547070 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C2986546 (UMLS CUI [4,1])
C0796679 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0598934 (UMLS CUI [5])
C0027651 (UMLS CUI [6,1])
C1512560 (UMLS CUI [6,2])
Systemic therapy Absent Liver carcinoma | Embolization | Chemoembolization | Chemotherapy by intra-arterial infusion | Ethanol Injection | Radiofrequency ablation | Cryosurgery
Item
the patient has not received prior systemic therapy for hcc. patients may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0013931 (UMLS CUI [2])
C0796679 (UMLS CUI [3])
C2045832 (UMLS CUI [4])
C4307245 (UMLS CUI [5])
C0850292 (UMLS CUI [6])
C0010408 (UMLS CUI [7])
Serum fasting glucose measurement | Hemoglobin A1c measurement | Glucose measurement
Item
the patient has fasting serum glucose < 160 mg/dl or below the uln and/or hemoglobin a1c < 7%. if baseline nonfasting glucose < 160 mg/dl, fasting glucose measurement is not required
boolean
C0583334 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0337438 (UMLS CUI [3])
Informed Consent
Item
the patient has the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
the patient has brain metastases
boolean
C0220650 (UMLS CUI [1])
Hepatitis
Item
the patient has acute hepatitis
boolean
C0019158 (UMLS CUI [1])
Poorly controlled diabetes mellitus
Item
the patient has poorly controlled diabetes mellitus. patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
boolean
C0554876 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset angina | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents
Item
the patient has congestive heart failure > class ii nyha, unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0340289 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0003195 (UMLS CUI [5,3])
Hemorrhage CTCAE Grades
Item
the patient has experienced a hemorrhage or bleeding event ≥ nci-ctcae grade 3 within 4 weeks prior first dose of study therapy
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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