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

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT03053596
• Lead Sponsor: Terumo Europe N.V.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-14
• Study Start: 2016-11
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-15
• Primary Completion: 2019-04-01
• Study Completion: 2019-10-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients, more than 18 years old, with unresectable hepatocellular carcinoma eligible for treatment with anthracyclin loaded LifePearls, allocated to TACE treatment at multidisciplinary tumor board and who agree to data collection in the registry by signing informed consent form.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver toxicity assessment based on routine CT scans	12 months

Secondary Outcome Measures

Name	Time	Method
Treatment efficacy based on response rate assessed by RECIST 1.1 criteria	3 months after final TACE
Safety based on recorded SAE assessed by CTCAE v4.03	12 months
Liver toxicity assessment based on routine blood tests: liver enzymes, phosphatase alkaline, GGT, CBC, bilirubin, albumin. Number of participants with changes in liver function related to TACE treatment.	12 months
Treatment efficacy based on response rate assessed by mRECIST criteria	3 months after final TACE

Trial Locations

Locations (7)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Hôpital Erasme; 🇧🇪 Brussels, Belgium

Hôpital Beaujon; 🇫🇷 Clinchamp, France

CHRU Lille; 🇫🇷 Lille, France

Hôpital Universitaire Saint-Eloi; 🇫🇷 Montpellier, France

Hôpital L'Archet II; 🇫🇷 Nice, France

Institut Gustave Roussy; 🇫🇷 Villejuif Cedex, France