ID

36069

Description

TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02435953

Link

https://clinicaltrials.gov/show/NCT02435953

Keywords

Versions (2)
  1. 4/13/19 4/13/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02435953

English

Eligibility Hepatocellular Carcinoma NCT02435953

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple hcc (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple hcc (4-10 lesions), each ≤ 7 cm in diameter
Description

Liver carcinoma multiple | Lesion Quantity | Lesion Diameter Largest | Lesion Quantity Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0443228
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1301886
no vascular invasion or etrahepatic metastases
Description

Tumor Vascular Invasion Absent | Neoplasm Metastasis Extrahepatic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0521157
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0332197
eastern cooperative oncology group performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh stage a or b
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C2347612
treatment naive
Description

Therapy naive

Data type

boolean

Alias
UMLS CUI [1]
C0919936
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a platelet counts of ＜40×109/l，prothrombin time activity ＜40%;
Description

Platelet Count measurement | Prothrombin time assay

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0033707
albumin ＞2.8 g/dl, total bilirubin ＜51.3 umol/l; alanine aminotransferase (alt) and aspartate transaminase（ast）＜5 times of upper limit
Description

Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201838
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
no evaluale target lesions
Description

Target Lesion Evaluable Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1516986
UMLS CUI [1,3]
C0332268
uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy
Description

Ascites Uncontrolled | Refractory Ascites | Bleeding varices | Encephalopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0085584
severe heart, brain or kidney diseases
Description

Heart Diseases Severe | Brain Diseases Severe | Kidney Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
previous or concurrent cancer that is distinct in primary site or histology from hcc
Description

Cancer Other | Primary tumor site Different Liver carcinoma | Histology Different Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0475447
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C4048239
UMLS CUI [3,2]
C1705242
UMLS CUI [3,3]
C2239176
pregnant women or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
be allergic to adriamycin, lobaplatin, mitomycin and iodized oil
Description

Hypersensitivity Adriamycin | Hypersensitivity Lobaplatin | Mitomycin allergy | Hypersensitivity Iodized Oil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0085752
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0165747
UMLS CUI [3]
C0570684
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0021972
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Similar models

Eligibility Hepatocellular Carcinoma NCT02435953

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma multiple | Lesion Quantity | Lesion Diameter Largest | Lesion Quantity Diameter
Item
multiple hcc (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple hcc (4-10 lesions), each ≤ 7 cm in diameter
boolean
C2239176 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0443228 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1301886 (UMLS CUI [4,3])
Tumor Vascular Invasion Absent | Neoplasm Metastasis Extrahepatic Absent
Item
no vascular invasion or etrahepatic metastases
boolean
C0521157 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh stage a or b
boolean
C2347612 (UMLS CUI [1])
Therapy naive
Item
treatment naive
boolean
C0919936 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Platelet Count measurement | Prothrombin time assay
Item
a platelet counts of ＜40×109/l，prothrombin time activity ＜40%;
boolean
C0032181 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
albumin ＞2.8 g/dl, total bilirubin ＜51.3 umol/l; alanine aminotransferase (alt) and aspartate transaminase（ast）＜5 times of upper limit
boolean
C0201838 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Target Lesion Evaluable Lacking
Item
no evaluale target lesions
boolean
C2986546 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Ascites Uncontrolled | Refractory Ascites | Bleeding varices | Encephalopathy
Item
uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0003962 (UMLS CUI [2,2])
C0333106 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
Heart Diseases Severe | Brain Diseases Severe | Kidney Diseases Severe
Item
severe heart, brain or kidney diseases
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006111 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Cancer Other | Primary tumor site Different Liver carcinoma | Histology Different Liver carcinoma
Item
previous or concurrent cancer that is distinct in primary site or histology from hcc
boolean
C1707251 (UMLS CUI [1])
C0475447 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C4048239 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant women or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Adriamycin | Hypersensitivity Lobaplatin | Mitomycin allergy | Hypersensitivity Iodized Oil
Item
be allergic to adriamycin, lobaplatin, mitomycin and iodized oil
boolean
C0020517 (UMLS CUI [1,1])
C0085752 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0165747 (UMLS CUI [2,2])
C0570684 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0021972 (UMLS CUI [4,2])
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