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10 patients receiving unilobar treatment: day 1=chemoembolization of first lobe of liver, day 14=chemoembolization of second lobe of liver, day 30=chemoembolization of first lobe of liver, day 44= chemoembolization of second lobe of liver; AND 10 patient receiving bilobar treatment: day 1=chemoembolization of both lobes of the liver, day 30=chemoembolization of both lobes of the liver

Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.

TACE with irinotecan loaded LifePearl

Hans Prenen, MD

Philippe Pereira, MD

Julien Taieb, MD

The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.

LifePearl-Iri Pharmacokinetic Study

Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan

Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38

Tmax will be estimated directly from concentration-time data

The trapezoidal rule will be used to calculate the area under the curve over 24 hours

Response rate (mRECIST criteria) 3 months after the first treatment

Ability to deliver ≥75% of the planned dose during the first chemoembolization

Sum of all doses delivered during the course of the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LifePearl-Iri Pharmacokinetic Study	NCT02547480	Metastatic Colo... mCRC	TACE with irino...	18 Years -	Terumo Europe N.V.
LifePearl-Iri Pharmacokinetic Study	NCT02547480	Metastatic Colo... mCRC	TACE with irino...	18 Years -	Terumo Europe N.V.

Spots Global Cancer Trial Database for tace with irinotecan loaded lifepearl