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

NCT03734068 | Unknown DMC

• 1 other identifier: LIFDOX
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Transarterial chemoembolization; Tumor response; Lifepearls

Outcome Measures

Primary Outcomes (1)

• Tumor response

  CT scan will be performed to assess tumor response

  6 months

Secondary Outcomes (3)

• Number of adverse events

  1 year

• time to progression

  1 months

• number of treatment required to achieve objective response in HCC patients

  1 year

Study Arms (1)

Chemoembolization

Chemoembolization Using LifePearl and Doxorubicin

Device: Chemoembolization Using LifePearl; Drug: Doxorubicin

Interventions

Chemoembolization Using LifePearl DEVICE

Chemoembolization Using LifePearl

Chemoembolization

Doxorubicin DRUG

Doxorubicin is loaded to LIfePearl

Chemoembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

un-resectable hepatocellular carcinoma that are indicated for TACE treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Group of Endovascular Oncology: lead

Study Sites (1)

Antonio Nicolini

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Antonio Nicolini, MD

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

  PRINCIPAL INVESTIGATOR

• Giammaria Fiorentini, MD

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

  STUDY CHAIR

Central Study Contacts

Antonio Nicolini, MD

CONTACT

+390255035604; anicolini54@gmail.com

Giammaria Fiorentini, MD

CONTACT

+390721364005; g.fiorentini@alice.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 7, 2018
• Study Start: June 13, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months
• Access Criteria: request by email to Principal investigator

Locations

IT (1)