Hepatocellular Carcinoma Clinical Trial
Official title:
LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma
The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the eight
in women and is the third most common cause of death from cancer worldwide. The overall
incidence of HCC remains high in developing countries and is steadily rising in most
industrialized countries.
Available treatment options depend on the size, number, and location of tumors; degree of
cirrhosis, if present; and comorbidities; overall performance status; patency of portal vein;
and presence of metastatic disease. They include surgical (liver resection, liver
transplantation), medical (e.g. sorafenib…), ablative (ethanol ablation, radiofrequency
ablation, cryoablation) and intra-arterial (chemoembolization, radioembolization) modalities.
Trans Arterial Chemo-Embolization (TACE) with various drugs (anthracyclines being among the
most commonly used ones) has been an important therapeutic option for treatment of patients
with intermediate stage HCC according to BCLC/EORTC guidelines (REF). In order to maximize
therapeutic efficacy of TACE, chemotherapy loadable beads were developed allowing to lower
systemic toxicity of chemotherapy, to deliver high and sustained chemotherapy concentration
to the tumor, and to prolong delivery of drug and embolization to the tumor.
The purpose of this registry is to evaluate liver and systemic toxicity, treatment efficacy,
and safety of Drug Elutable Beads -TACE using anthracyclin loaded Life-Pearls -TACE for
unresectable hepatocellular carcinoma.
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