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

Hepatocellular Carcinoma Clinical Trial

Official title:

LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053596
• Other study ID #: T127E2
• Status: Completed
• Start date: November 2016
• Est. completion date: October 8, 2019

Study information

• Verified date: January 2020
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 8, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• DEB-TACE using anthracyclin loaded LifePearl™
The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearl™ for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Hôpital Erasme	Brussels
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver toxicity assessment based on routine CT scans		12 months
Secondary	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
Secondary	Treatment efficacy based on response rate assessed by mRECIST criteria		3 months after final TACE
Secondary	Treatment efficacy based on response rate assessed by RECIST 1.1 criteria		3 months after final TACE
Secondary	Safety based on recorded SAE assessed by CTCAE v4.03		12 months