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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
KUL
Leuven, Belgium
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Klinikum Bogenhausen, Städt. Klinikum München GmbH
Munich, Germany
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
Time frame: 2 days
Time to reach Cmax (Tmax)
Tmax will be estimated directly from concentration-time data
Time frame: 2 days
Area Under the Curve (AUC)
The trapezoidal rule will be used to calculate the area under the curve over 24 hours
Time frame: 1 day
Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment
Time frame: 1 month
Overall Survival
Time frame: 12 months
Progression-Free Survival
Time frame: 12 months
Response rate
Response rate (mRECIST criteria) 3 months after the first treatment
Time frame: 3 months
Technical success - treatment delivery
Ability to deliver ≥75% of the planned dose during the first chemoembolization
Time frame: 1 day
Technical success - total dose delivered
Sum of all doses delivered during the course of the study
Time frame: 6 weeks
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