Hepatocellular Carcinoma Clinical Trial
Official title:
Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC.
This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical
performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of
unresectable HCC by chemoembolization. Data from this study will be used as supportive data
post CE-mark approval.
The main objective of the study is to evaluate the safety and pharmacokinetic profile of
LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver
cancer (HCC) by chemoembolization. This will be measured as treatment-related complications
and plasma levels of Doxorubicin in peripheral blood.
In addition, objective tumour response will be assessed by computed tomography or MRI.
Two cohorts of patients will be evaluated:
Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will
assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with
Cohort I.
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