Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in HCC

NCT ID: NCT03734068

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-13
• Study Completion Date: 2021-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemoembolization

Chemoembolization Using LifePearl and Doxorubicin

Chemoembolization Using LifePearl

Intervention Type: DEVICE

Chemoembolization Using LifePearl

Doxorubicin

Intervention Type: DRUG

Doxorubicin is loaded to LIfePearl

Interventions

Chemoembolization Using LifePearl

Chemoembolization Using LifePearl

Intervention Type: DEVICE

Doxorubicin

Doxorubicin is loaded to LIfePearl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with confirmed diagnosis of HCC with CT scan, MRI or biopsy
• Patient with un-resectable HCC and not indicated for other radical therapies, or waiting for transplant
• Multinodular or single nodular tumor extended to <50% of the liver
• Hyper vascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
• At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
• No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
• Eastern Cooperative Oncology Group performance status is 0 - 1
• Proper blood, liver, renal, heart function
• Over 18 years old
• Expected survival more than 6 months
• Prior written patient consent

Exclusion Criteria

• Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
• Tumor burden involving more than 50% of the liver
• History of biliary tract repair or endoscopic biliary tract treatment
• Clinically important refractory ascites or pleural fluid
• Any contraindications for hepatic embolization procedures
• Any contraindication for doxorubicin administration
• Contrast media allergy contraindicating angiography
• Acute or active cardiac, hepatic or renal diseases
• Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Group of Endovascular Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Nicolini, MD

Role: PRINCIPAL_INVESTIGATOR

UOSD Radiologia Interventistica, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza, 28, 20122 Milano, Italia

Giammaria Fiorentini, MD

Role: STUDY_CHAIR

Department of Oncology-Hematology, Azienda Ospedaliera Ospedali Riuniti Marche Nord, P.O. San Salvatore, via C. Lombroso 1, 62122 Pesaro, Italy

Locations

Antonio Nicolini

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Nicolini, MD

Role: CONTACT

anicolini54@gmail.com

+390255035604

Giammaria Fiorentini, MD

Role: CONTACT

g.fiorentini@alice.it

+390721364005

Facility Contacts

Antonio Nicolini, MD

Role: primary

anicolini54@gmail.com

+390255035604

Giammaria Fiorentini, MD

Role: backup

g.fiorentini@alice.it

+390721364005

Other Identifiers

LIFDOX

Identifier Type: -

Identifier Source: org_study_id