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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: DEB-TACE using anthracyclin loaded LifePearl™


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver toxicity assessment based on routine CT scans |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, LifePearl