Informações:
Falhas:
ID
40928
Descrição
Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02267213
Link
https://clinicaltrials.gov/show/NCT02267213
Palavras-chave
Versões (1)
- 06/06/2020 06/06/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
6 de junho de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02267213
Eligibility Hepatocellular Carcinoma NCT02267213
- StudyEvent: Eligibility
Similar models
Eligibility Hepatocellular Carcinoma NCT02267213
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])