Clinical trial NCT03053596: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable HCC (PARIS Registry)
Official title: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: HCC
LifePearl
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Liver toxicity assessment based on routine CT scans
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: Treatment efficacy based on response rate assessed by mRECIST criteria
timeFrame: 3 months after final TACE
measure: Treatment efficacy based on response rate assessed by RECIST 1.1 criteria
timeFrame: 3 months after final TACE
measure: Safety based on recorded SAE assessed by CTCAE v4.03
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Clinchamp
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: CHRU Lille
city: Montpellier
country: France
facility: Hôpital Universitaire Saint-Eloi
city: Nice
country: France
facility: Hôpital L'Archet II
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Gustave Roussy, France
name: Thierry de Baere, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11):3405. doi: 10.3390/cancers12113405.