LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable HCC (PARIS Registry)

Last updated: January 24, 2020
Sponsor: Terumo Europe N.V.
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Liver Disorders

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT03053596
T127E2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients, more than 18 years old, with unresectable hepatocellular carcinoma eligiblefor treatment with anthracyclin loaded LifePearls, allocated to TACE treatment atmultidisciplinary tumor board and who agree to data collection in the registry bysigning informed consent form.

Exclusion

Exclusion Criteria:

  • This is an observational registry and there are no exclusion criteria apart frompatient refusal.

Study Design

Total Participants: 102
Study Start date:
November 01, 2016
Estimated Completion Date:
October 08, 2019

Study Description

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.

Connect with a study center

  • Cliniques Universitaires Saint Luc

    Brussels,
    Belgium

    Site Not Available

  • Hôpital Erasme

    Brussels,
    Belgium

    Site Not Available

  • Hôpital Beaujon

    Clinchamp,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • Hôpital Universitaire Saint-Eloi

    Montpellier,
    France

    Site Not Available

  • Hôpital L'Archet II

    Nice,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex,
    France

    Site Not Available

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