Informações:
Falhas:
ID
14590
Descrição
Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02072486
Link
https://clinicaltrials.gov/show/NCT02072486
Palavras-chave
Versões (1)
- 22/04/2016 22/04/2016 -
Transferido a
22 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Adult Hepatocellular Carcinoma NCT02072486
Eligibility Adult Hepatocellular Carcinoma NCT02072486
- StudyEvent: Eligibility
Similar models
Eligibility Adult Hepatocellular Carcinoma NCT02072486
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Informed consent
Item
subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
boolean
C0021430 (UMLS CUI [1])
hepatocellular carcinoma
Item
outpatients with histologically/cytologically documented or radiographically diagnosed unresectable hepatocellular carcinoma (hcc) who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made; radiographic diagnosis needs typical findings of hcc by a radiographic method, i.e. on multi-dimensional dynamic computed tomography (ct), ct hepatic arteriography (ctha)/ct arterial portography (ctap) or magnetic resonance imaging (mri)
boolean
C2239176 (UMLS CUI [1])
life expectancy
Item
patients must have a life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI [1])
bleeding diathesis
Item
patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
boolean
C0005779 (UMLS CUI [1])
intercurrent illness
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C3640977 (UMLS CUI [1])
pregnant or nursing
Item
pregnant or nursing female subjects
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
Protocol Compliance
Item
unwilling or unable to follow protocol requirements
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
Study drug
Item
any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
boolean
C1709261 (UMLS CUI [1])
anti-angiogenic therapy
Item
patients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib; prior treatment with liver directed, ablative or surgical therapies will be permitted as long as there is documented progression justifying the need for starting sorafenib therapy
boolean
C0596087 (UMLS CUI [1])
severe coronary artery disease
Item
no known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow up
boolean
C0010068 (UMLS CUI [1])
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