Observational Prospective Study on Chemoembolization With Doxorubicin for Unresectable Hepatocellular Carcinoma

NCT01891539 | Unknown DMC

• 1 other identifier: DEBDOX01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 rising in most industrialized countries. TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence within the tumor. The comparison of efficacy and safety of TACE with drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response and time to progression in the group was significantly higher than that of the cTACE group. TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to the treatment of HCC. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.

Conditions

Liver Cell Carcinoma Non-resectable

Keywords

Hepatocellular carcinoma, doxorubicin, chemoembolization

Outcome Measures

Primary Outcomes (1)

• tumor response

  CT scan evaluation according to RECIST 1.1

  4 months

Secondary Outcomes (2)

• survival rate

  one year

• time to progression

  1 year

Study Arms (1)

doxorubicin

Day +1: Lobar Infusion ( lobe with dominant disease) of Doxorubicin preloaded into 2 ml of drug-eluting microspheres. Second lobar infusion of Doxorubicin preloaded into 2 ml of drug eluting microspheres can be administered at the same time contralaterally or in a further TACE Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Patients with confirmed diagnosis of HCC
• Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
• Multinodular or single nodular tumor more than 5cm
• Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during 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
• Eastern Cooperative Oncology Group performance status is 0 - 1
• Proper blood, liver, renal, heart functionality
• more than 18 years old
• Expected survival more than 6 months
• Prior written 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)

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, PU, 61122, Italy

RECRUITING

Related Publications (2)

• Fiorentini G. A new tool to enhance the efficacy of chemoembolization to treat primary and metastatic hepatic tumors. Expert Opin Drug Deliv. 2011 Apr;8(4):409-13. doi: 10.1517/17425247.2011.565327. Epub 2011 Mar 18.

  PMID: 21413909 RESULT

• Fiorentini G, Campanini A, Dazzi C, Davitti B, Graziani G, Priori T, Ricci Bitti R, Angelini L. Chemoembolization in liver malignant involvement. Experiences on 17 cases. Minerva Chir. 1994 Apr;49(4):281-5.

  PMID: 8072703 RESULT

Related Links

• International group of endovascular oncology (IGEVO) website

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Giammaria Fiorentini, MD

  International Group of Endovascular Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donatella Sarti, PhD

CONTACT

+39072136; igevo.datamanager@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 3, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)