Hepatocellular Carcinoma Clinical Trial
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)
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.
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.
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