ID

40928

Description

Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02267213

Lien

https://clinicaltrials.gov/show/NCT02267213

Mots-clés

Versions (1)
  1. 06/06/2020 06/06/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 juin 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02267213

Anglais

Eligibility Hepatocellular Carcinoma NCT02267213

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
radiological diagnosis of hepatic tumor(s) by contrast-enhanced study
Description

Liver neoplasms Imaging study requiring contrast

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023903
UMLS CUI [1,2]
C3242003
subjects with advanced hcc who are not eligible for surgical resection or loco-regional therapy.
Description

Liver carcinoma Advanced | Ineligibility Excision | Ineligibility Therapy Locoregional

Type de données

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0728940
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1947913
subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic pd (as per recist v1.1). prior sorafenib use should be ≥ 400 mg/day for at least 14 days.
Description

Sorafenib failed | Intolerance to Sorafenib | Progressive Disease | Sorafenib U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1516119
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C1516119
UMLS CUI [4,2]
C0456683
eastern cooperative oncology group (ecog) performance status of ≤ 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
child pugh score ≤ 6;
Description

Child-Pugh - Total Score

Type de données

boolean

Alias
UMLS CUI [1]
C4055253
a life expectancy of at least 12 weeks or more
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of hcc.
Description

Targeted Therapy Systemic Liver carcinoma | Systemic Chemotherapy Liver carcinoma | Exception Sorafenib

Type de données

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1516119
subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline.
Description

Sorafenib Recent | Toxicity Sorafenib Related | Toxicity CTCAE Grades failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516119
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C1516728
UMLS CUI [3,3]
C0231175
subjects who have undergone liver transplantation surgery.
Description

Transplantation of liver

Type de données

boolean

Alias
UMLS CUI [1]
C0023911
major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.
Description

Major surgery | Exception Medical device implantation Intravenous infusion | Puncture of liver Percutaneous

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0877318
UMLS CUI [2,3]
C0021440
UMLS CUI [3,1]
C3698142
UMLS CUI [3,2]
C0522523
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Similar models

Eligibility Hepatocellular Carcinoma NCT02267213

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Liver neoplasms Imaging study requiring contrast
Item
radiological diagnosis of hepatic tumor(s) by contrast-enhanced study
boolean
C0023903 (UMLS CUI [1,1])
C3242003 (UMLS CUI [1,2])
Liver carcinoma Advanced | Ineligibility Excision | Ineligibility Therapy Locoregional
Item
subjects with advanced hcc who are not eligible for surgical resection or loco-regional therapy.
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1947913 (UMLS CUI [3,3])
Sorafenib failed | Intolerance to Sorafenib | Progressive Disease | Sorafenib U/day
Item
subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic pd (as per recist v1.1). prior sorafenib use should be ≥ 400 mg/day for at least 14 days.
boolean
C1516119 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C1516119 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 1
boolean
C1520224 (UMLS CUI [1])
Child-Pugh - Total Score
Item
child pugh score ≤ 6;
boolean
C4055253 (UMLS CUI [1])
Life Expectancy
Item
a life expectancy of at least 12 weeks or more
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Targeted Therapy Systemic Liver carcinoma | Systemic Chemotherapy Liver carcinoma | Exception Sorafenib
Item
subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of hcc.
boolean
C2985566 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1883256 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
Sorafenib Recent | Toxicity Sorafenib Related | Toxicity CTCAE Grades failed
Item
subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline.
boolean
C1516119 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Transplantation of liver
Item
subjects who have undergone liver transplantation surgery.
boolean
C0023911 (UMLS CUI [1])
Major surgery | Exception Medical device implantation Intravenous infusion | Puncture of liver Percutaneous
Item
major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0877318 (UMLS CUI [2,2])
C0021440 (UMLS CUI [2,3])
C3698142 (UMLS CUI [3,1])
C0522523 (UMLS CUI [3,2])
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