Prospectived, Randomized, Blinded and Controlled investigation of Hepasphere/Quadrasphere microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2011-001477-14-IT
• Date of registration: 16/05/2012
• Prospective Registration: Yes
• Primary sponsor: MERIT MEDICAL SYSTEMS, INC.
• Public title: Prospectived, Randomized, Blinded and Controlled investigation of Hepasphere/Quadrasphere microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer.
• Scientific title: Phase 3 Prospective,Randomized, blinded and controlled investigation of Hepasphere/Quadrasphere microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. This Study is Phase IV in the European community. - HiQuality Study Protocol HCC-P3-11-001
• Date of first enrolment: 15/06/2012
• Target sample size: 520
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001477-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: lipiodol and doxorubicin Number of treatment arms in the trial: 2

Countries of recruitment

European Union, Italy, United States

Contacts

• Name: Clinical Manager
• Affiliation: Olivier Raclot

• Name: Clinical Manager
• Affiliation: Olivier Raclot

Key inclusion & exclusion criteria

Inclusion criteria:
a. Age 18 or older b. Patient has signed informed consent c. Patient must have a diagnosist of hepatocellular cancer confirmed by at least one of the following: -histological confirmation -MRI result consistent with cirrhosis AND at least one solid liver lesion >2 cm with early enhancement and delayed enhancement washout, regardless of apha fetoprotein level -Alpha fetoprotein level >400 ng/mL AND evidence of at least one solid lesion >2 cm, regardless of specific imaging characteristics on MRI d. Patient must not be suitable for treatment by resection or percutaneous albation at time of study entry. Patients not suitable for ablation due to lesion location may be enrolled e. Patient MUST meet at least ONE of the following criteria: -Stage Child-Pugh B 7 -Recurrent HCC -Performance status ECOG 1 f. Patient has a life expectancy of at least 6 months g. Absence of occlusive thrombus to the main portal trunk
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion criteria:
a. Current or previous treatment with chemo or radiation therapy or sorafenib b. Previous treatment with any form of transarterial embolization for HCC c. Patients with current or history of any other cancer except nonmelanomatous skin cancer d. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive e. Performance status ECOG>2 f. Child-Pugh score >7 g. Active gastroinstestinal bleeding h. Evidence of uncorrectable bleeding diathesis i. Extrahepatice spread of the HCC j. Total Bilirubin >3mg/dL k. >50% tumor involvement of the liver l. Infiltrative or diffuse HCC m. Encephalopathy not adequately controlled medically. n. Prescence of ascites not controlled medically. o. Presence of medically relevant localized or systemic infection,other than hepatitis B,C,D,E or G p. Any contraindication for MRI q. Allergy to contrast media that cannot be managed with prophylaxis r. Allergy to iodized oit s. Any contraindication to arteriography t. Any contraindication for doxorubicin administration, including the following: -White blood cell count <3000 cells/mm -Absolute Neutrophil <1500 cells/mm -Cardiac ejection fraction <50% -Other condition deemed exclusionary by physician u. Any contraindication for hepatic embolization, including the following: -Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization -Hepatofugal blood flow -Serum creatinine >2mg/dL -Uncorrectable impaired clotting 1. Platelet <50000/mm 2. International Normalized Ratio (INR)>1.4 3. aPTT outside normal limits - AST >5x upper limit of normal for lab - ALT >5x upper limt of normal for lab -Severe peripheral vascular disease -Other condition demmed exclusionary by physician


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Liver Cancer
MedDRA version: 14.1 Level: LLT Classification code 10024722 Term: Liver, cancer of, primary System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: DOXORUBICINA ESP*INIET 1FL50MG
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: LIPIODOL ULTRAFLUIDO*F 10ML
Pharmaceutical Form: Solution for intravesical use
INN or Proposed INN: IODINATED (I 131) ETHYL ESTERS OF THE FATTY ACIDS OF POPPY-SEED OIL
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 2 years

Main Objective: Evaluate overall survival in patients treated with HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with particle PVA

Primary end point(s): The primary study endpoint will be overall survival.

Secondary Objective: Evaluate adverse events in patients treated with HepaSphere/QuadraSphere compared to those treated with conventional transarterial chemoembolization with particle PVA

Secondary Outcome(s)

Secondary end point(s): Tumor response by mRECIST criteria Overall tumor response Treatment related to adverse events

Timepoint(s) of evaluation of this end point: 6 months

Secondary ID(s)

NCT01387932

HCC-P3-11-01

Source(s) of Monetary Support

Merit Medical