ID

44538

Description

Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion; ODM derived from: https://clinicaltrials.gov/show/NCT01857726

Link

https://clinicaltrials.gov/show/NCT01857726

Keywords

Versions (2)
  1. 2/22/20 2/22/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01857726

English

Eligibility Hepatocellular Carcinoma NCT01857726

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with clinical or histological diagnosis of hcc based on the guidelines of the ajcc
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
patients with advanced hcc with invasion of major branch(es) of portal vein in the arterial phase of dynamic ct or mri
Description

Liver carcinoma Advanced | Invasion Branch of portal vein Major CT | Invasion Branch of portal vein Major MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0226736
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0226736
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0024485
patients who have received previous local therapy treatments (rfa, pei, cryoablation, surgery, resection) are eligible
Description

Local Therapy Previous | Radiofrequency ablation | Percutaneous Ethanol Injection | Cryosurgery | Operative Surgical Procedures | Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0850292
UMLS CUI [3]
C1880568
UMLS CUI [4]
C0010408
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0728940
age : 18 years to 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh class a (child-pugh score 5-6)
Description

Child-Pugh Classification | Child-Pugh Score

Data type

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2]
C4055253
adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Description

Bone Marrow function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
wbc count > 2,000/mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count > 1,000/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hb ≧ 8.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
platelet count ≧ 50,000 /mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin ≦ 3 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
adequate clotting function: inr < 2.3 or < 6sec
Description

Coagulation function | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C3516400
UMLS CUI [2]
C0525032
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
child-pugh score ≧ 7
Description

Child-Pugh Score

Data type

boolean

Alias
UMLS CUI [1]
C4055253
ecog performance status ≧ 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dl
Description

Chronic Kidney Disease | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0201976
history of organ allograft
Description

Organ allograft

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
patients with uncontrolled co-morbidity which needs treatment
Description

Comorbidity Uncontrolled | Treatment required

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0332121
patients who have received prior systemic chemotherapy
Description

Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1883256
patients with extrahepatic metastasis
Description

Metastasis Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
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Similar models

Eligibility Hepatocellular Carcinoma NCT01857726

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
patients with clinical or histological diagnosis of hcc based on the guidelines of the ajcc
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma Advanced | Invasion Branch of portal vein Major CT | Invasion Branch of portal vein Major MRI
Item
patients with advanced hcc with invasion of major branch(es) of portal vein in the arterial phase of dynamic ct or mri
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1269955 (UMLS CUI [2,1])
C0226736 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1269955 (UMLS CUI [3,1])
C0226736 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
Local Therapy Previous | Radiofrequency ablation | Percutaneous Ethanol Injection | Cryosurgery | Operative Surgical Procedures | Excision
Item
patients who have received previous local therapy treatments (rfa, pei, cryoablation, surgery, resection) are eligible
boolean
C1517925 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0850292 (UMLS CUI [2])
C1880568 (UMLS CUI [3])
C0010408 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0728940 (UMLS CUI [6])
Age
Item
age : 18 years to 80 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification | Child-Pugh Score
Item
child-pugh class a (child-pugh score 5-6)
boolean
C4050412 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
Bone Marrow function | Liver function
Item
adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
White Blood Cell Count procedure
Item
wbc count > 2,000/mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 1,000/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hb ≧ 8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≧ 50,000 /mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≦ 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Coagulation function | International Normalized Ratio
Item
adequate clotting function: inr < 2.3 or < 6sec
boolean
C3516400 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Child-Pugh Score
Item
child-pugh score ≧ 7
boolean
C4055253 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≧ 3
boolean
C1520224 (UMLS CUI [1])
Chronic Kidney Disease | Creatinine measurement, serum
Item
patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dl
boolean
C1561643 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Organ allograft
Item
history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Treatment required
Item
patients with uncontrolled co-morbidity which needs treatment
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2])
Systemic Chemotherapy
Item
patients who have received prior systemic chemotherapy
boolean
C1883256 (UMLS CUI [1])
Metastasis Extrahepatic
Item
patients with extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
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