Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Terumo Europe N.V.
With
Federation Francophone de Cancerologie Digestive
Universitaire Ziekenhuizen KU Leuven
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient is at least 18 years old
Histologically proven mCRC
At least 1 measurable liver metastasis \> 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver)
No portal vein involvement
Performance status 0 or 1
Life Expectancy ≥ 3m
Adequate Hematologic function (ANC≥1.5 10\^9/l; PLT≥75 10\^9/l; INR (international normalized ratio) ≤1.3)
Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN)
Less than 50% liver tumor replacement
Patient has provided written informed consent
Patient is affiliated to social security or equivalent system (France only)
You may not be if
Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment)
Previous liver embolization
Contraindication for intra-arterial embolization and local irinotecan administration
Allergy to contrast media
Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort
Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
Patient is under judicial protection (France only)
Clareo Health | LifePearl-Iri Pharmacokinetic Study
