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

International Group of Endovascular Oncology

Status

Unknown

Conditions

Hepatocellular Carcinoma

Treatments

Device: Chemoembolization Using LifePearl

Drug: Doxorubicin

Study type

Observational

Funder types

Other

Identifiers

NCT03734068

LIFDOX

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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