Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-03-12 @ 10:43 AM
Study NCT ID:
NCT03734068
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2018-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in HCC
Sponsor:
International Group of Endovascular Oncology
Organization:
Study Overview
Official Title:
Observational Prospective Study on Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in Patients With Primary Un-resectable Liver Cancer (Hepatocellular Carcinoma)
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFDOX
Brief Summary:
The aim of this study is to collect data on efficacy and tolerability on a large series of patient of different Italian hospitals in order to support the validation of LifePearl with robust and consistent clinical evidence. Since TACE in treating HCC is considered a more common and accepted approach, this study will be focused on evaluating treatment efficacy and safety of LIFDOX for un-resectable hepatocellular carcinoma.
Detailed Description:
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh 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 increasing in most industrialized countries.
Trans-arterial chemoembolization (TACE) is the most used treatment for patients with un-resectable hepatocellular carcinoma (HCC), because it improves median survival and tumor response. The application of drug-eluting bead to this procedure has significantly increased TACE efficacy, while reducing systemic drug leakage, liver toxicity and adverse events. These beads deliver the toxic drugs directly to the arterial capillary bed of the tumor, and release them in a controlled manner. This method lower the systemic exposure to chemotherapeutics, while increasing their local concentration, resulting in a greater tissue necrosis than classic trans-arterial chemoembolization.
TACE is indicated for patients with multinodular liver cancer that have no vascular invasion and extrahepatic diffusion. TACE is also strongly suggested for patients with un-resectable liver primary tumor (HCC and cholangiocarcinoma) and chemo-resistant liver metastases, mainly from colorectal cancer carcinoma (CRC), and is widely performed in 32% of patients with un-resectable HCC at initial diagnosis and in 58% of those with recurrent HCC. It appears, moreover, to be particularly useful if carried out with new embolization materials, such as doxorubicin.
Trans-arterial chemoembolization is constantly improving; from the original conventional TACE using Lipiodol and sponge particles, some years ago it evolved into precision TACE, thanks to the availability of drug-eluting microspheres. Microspheres retain the ability to bind positively charged chemotherapeutic drugs (i.e.: doxorubicin) and release them in a prolonged and sustained kinetic at tumor site while determining a permanent embolization of the feeding arteries. Consequently, less systemic exposure of drug is observed, with a benefit for the patients in term of toxicity, quality of life and hospitalization.
Recently, new drug-eluting beads in polyethylene glycol has been made available, termed LifePearl Polyethylene glycol drug eluting microspheres (Terumo, Microvention, Tustin, CA, USA), which are offered as a syringe presentation, for an easier loading process. More interestingly, LifePearl are precisely calibrated, in a range ≤ 50 micron, potentially leading to a more distal and targeted distribution into the tissues; in addition, they are endowed with a prolonged time in suspension after dilution in contrast medium, which makes the administration more smooth, predictable and reproducible. Because of the above improvements, LifePearl are now widely used in several hospital for the Transarterial chemoembolization as everyday clinical practice, for the hepatic intra-arterial infusion of doxorubicin or irinotecan respectively for the therapy of primary and metastatic liver cancer.
The aim of this study is to collect data on efficacy and tolerability on a large series of patient of different Italian hospitals in order to support the validation of LifePearl with robust and consistent clinical evidence. Since TACE in treating HCC is considered a more common and accepted approach, this study will be focused on evaluating treatment efficacy and safety of LIFDOX for un-resectable hepatocellular carcinoma.
Trans-arterial chemoembolization (TACE) is the most used treatment for patients with un-resectable hepatocellular carcinoma (HCC), because it improves median survival and tumor response. The application of drug-eluting bead to this procedure has significantly increased TACE efficacy, while reducing systemic drug leakage, liver toxicity and adverse events. These beads deliver the toxic drugs directly to the arterial capillary bed of the tumor, and release them in a controlled manner. This method lower the systemic exposure to chemotherapeutics, while increasing their local concentration, resulting in a greater tissue necrosis than classic trans-arterial chemoembolization.
TACE is indicated for patients with multinodular liver cancer that have no vascular invasion and extrahepatic diffusion. TACE is also strongly suggested for patients with un-resectable liver primary tumor (HCC and cholangiocarcinoma) and chemo-resistant liver metastases, mainly from colorectal cancer carcinoma (CRC), and is widely performed in 32% of patients with un-resectable HCC at initial diagnosis and in 58% of those with recurrent HCC. It appears, moreover, to be particularly useful if carried out with new embolization materials, such as doxorubicin.
Trans-arterial chemoembolization is constantly improving; from the original conventional TACE using Lipiodol and sponge particles, some years ago it evolved into precision TACE, thanks to the availability of drug-eluting microspheres. Microspheres retain the ability to bind positively charged chemotherapeutic drugs (i.e.: doxorubicin) and release them in a prolonged and sustained kinetic at tumor site while determining a permanent embolization of the feeding arteries. Consequently, less systemic exposure of drug is observed, with a benefit for the patients in term of toxicity, quality of life and hospitalization.
Recently, new drug-eluting beads in polyethylene glycol has been made available, termed LifePearl Polyethylene glycol drug eluting microspheres (Terumo, Microvention, Tustin, CA, USA), which are offered as a syringe presentation, for an easier loading process. More interestingly, LifePearl are precisely calibrated, in a range ≤ 50 micron, potentially leading to a more distal and targeted distribution into the tissues; in addition, they are endowed with a prolonged time in suspension after dilution in contrast medium, which makes the administration more smooth, predictable and reproducible. Because of the above improvements, LifePearl are now widely used in several hospital for the Transarterial chemoembolization as everyday clinical practice, for the hepatic intra-arterial infusion of doxorubicin or irinotecan respectively for the therapy of primary and metastatic liver cancer.
The aim of this study is to collect data on efficacy and tolerability on a large series of patient of different Italian hospitals in order to support the validation of LifePearl with robust and consistent clinical evidence. Since TACE in treating HCC is considered a more common and accepted approach, this study will be focused on evaluating treatment efficacy and safety of LIFDOX for un-resectable hepatocellular carcinoma.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: