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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-TACE using anthracyclin loaded LifePearl™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver toxicity assessment based on routine CT scans | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.
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| Name | Affiliation | Role |
|---|---|---|
| Thierry de Baere, MD | Institut Gustave Roussy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Brussels | Belgium | ||||
| Hôpital Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33212917 | Derived | 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. |
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| 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 |
| 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 | France |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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