ID

44214

Beschreibung

HAIC Using Oxaliplatin Plus Fluorouracil/Leucovorin for Patients With Locally Advanced HCC; ODM derived from: https://clinicaltrials.gov/show/NCT02436044

Link

https://clinicaltrials.gov/show/NCT02436044

Stichworte

Versionen (2)
  1. 13.04.19 13.04.19 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02436044

Englisch

Eligibility Hepatocellular Carcinoma NCT02436044

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
no extrahepatic spread on imaging, and filfill one of them as follows: 1.multiple hcc lesions,＞ 5.0 cm in diameter;2.portal venous hepatic vein/tumor thrombus or arteriovenous/portal fistula;3.direct invasion adjacent organs except gallbladder or penetrate the peritoneum;4.diffuse hcc.
Beschreibung

Neoplasm Metastasis Extrahepatic Absent Imaging | Liver carcinoma Multiple lesions | Lesion Diameter | Portal vein Tumor thrombus | Hepatic vein Tumor thrombus | Arteriovenous fistula | Tumor Cell Invasion Organs Adjacent | Exception Gallbladder | Liver carcinoma Diffuse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0011923
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0577305
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [4,1]
C1305775
UMLS CUI [4,2]
C3163918
UMLS CUI [5,1]
C0019155
UMLS CUI [5,2]
C3163918
UMLS CUI [6]
C0003855
UMLS CUI [7,1]
C1269955
UMLS CUI [7,2]
C0178784
UMLS CUI [7,3]
C0205117
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0016976
UMLS CUI [9,1]
C2239176
UMLS CUI [9,2]
C0205219
eastern cooperative oncology group performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

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

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
at least one evaluable intrahepatic target lesions
Beschreibung

Target Lesion intrahepatic Evaluable Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C1516986
UMLS CUI [1,4]
C1265611
previous accept sorafenib but stoped for more than 4 weeks because of disease progression or intolerance to sorafenib or refused to recieved sorafenib
Beschreibung

Sorafenib | Sorafenib Discontinued | Disease Progression | Intolerance to Sorafenib | Sorafenib Refused

Datentyp

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1516119
UMLS CUI [5,1]
C1516119
UMLS CUI [5,2]
C1705116
stoped for more than 4 weeks after local treatments(surgical resection, radiofrequency ablation, transcatheter arterial chemoembolization) of tumor if presence
Beschreibung

Local Therapy Tumor | Excision | Radiofrequency ablation | Transarterial Chemoembolization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0027651
UMLS CUI [2]
C0728940
UMLS CUI [3]
C0850292
UMLS CUI [4]
C3539919
sign the informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
ever received oxaliplatin or fluorouracil/leucovorin;
Beschreibung

oxaliplatin | Fluorouracil | Leucovorin

Datentyp

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0016360
UMLS CUI [3]
C0023413
a platelet counts of > 60,000/mm3, prothrombin time activity ＜40%;
Beschreibung

Platelet Count measurement | Prothrombin time assay

Datentyp

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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0201838
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
Beschreibung

Ascites Uncontrolled | Refractory Ascites | Bleeding varices | Encephalopathy

Datentyp

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
Beschreibung

Heart Diseases Severe | Brain Diseases Severe | Kidney Diseases Severe

Datentyp

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
Beschreibung

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

Datentyp

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;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
allergy to fluorouracil, oxaliplatin, leucovorin calcium or iodine contrast agent.
Beschreibung

Fluorouracil allergy | Hypersensitivity Oxaliplatin | Hypersensitivity Leucovorin Calcium | Iodine contrast allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0570698
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0069717
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0731033
UMLS CUI [4]
C4022917
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT02436044

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Neoplasm Metastasis Extrahepatic Absent Imaging | Liver carcinoma Multiple lesions | Lesion Diameter | Portal vein Tumor thrombus | Hepatic vein Tumor thrombus | Arteriovenous fistula | Tumor Cell Invasion Organs Adjacent | Exception Gallbladder | Liver carcinoma Diffuse
Item
no extrahepatic spread on imaging, and filfill one of them as follows: 1.multiple hcc lesions,＞ 5.0 cm in diameter;2.portal venous hepatic vein/tumor thrombus or arteriovenous/portal fistula;3.direct invasion adjacent organs except gallbladder or penetrate the peritoneum;4.diffuse hcc.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
C2239176 (UMLS CUI [2,1])
C0577305 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C1305775 (UMLS CUI [4,1])
C3163918 (UMLS CUI [4,2])
C0019155 (UMLS CUI [5,1])
C3163918 (UMLS CUI [5,2])
C0003855 (UMLS CUI [6])
C1269955 (UMLS CUI [7,1])
C0178784 (UMLS CUI [7,2])
C0205117 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0016976 (UMLS CUI [8,2])
C2239176 (UMLS CUI [9,1])
C0205219 (UMLS CUI [9,2])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh stage a or b
boolean
C4050412 (UMLS CUI [1])
Target Lesion intrahepatic Evaluable Quantity
Item
at least one evaluable intrahepatic target lesions
boolean
C2986546 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C1516986 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Sorafenib | Sorafenib Discontinued | Disease Progression | Intolerance to Sorafenib | Sorafenib Refused
Item
previous accept sorafenib but stoped for more than 4 weeks because of disease progression or intolerance to sorafenib or refused to recieved sorafenib
boolean
C1516119 (UMLS CUI [1])
C1516119 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C1516119 (UMLS CUI [4,2])
C1516119 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
Local Therapy Tumor | Excision | Radiofrequency ablation | Transarterial Chemoembolization
Item
stoped for more than 4 weeks after local treatments(surgical resection, radiofrequency ablation, transcatheter arterial chemoembolization) of tumor if presence
boolean
C1517925 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
C0850292 (UMLS CUI [3])
C3539919 (UMLS CUI [4])
Informed Consent
Item
sign the informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
oxaliplatin | Fluorouracil | Leucovorin
Item
ever received oxaliplatin or fluorouracil/leucovorin;
boolean
C0069717 (UMLS CUI [1])
C0016360 (UMLS CUI [2])
C0023413 (UMLS CUI [3])
Platelet Count measurement | Prothrombin time assay
Item
a platelet counts of > 60,000/mm3, prothrombin time activity ＜40%;
boolean
C0032181 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased
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])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
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])
Fluorouracil allergy | Hypersensitivity Oxaliplatin | Hypersensitivity Leucovorin Calcium | Iodine contrast allergy
Item
allergy to fluorouracil, oxaliplatin, leucovorin calcium or iodine contrast agent.
boolean
C0570698 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0069717 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0731033 (UMLS CUI [3,2])
C4022917 (UMLS CUI [4])
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