HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
NCT ID: NCT01387932
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
235 participants
INTERVENTIONAL
2011-06-30
2021-02-28
Brief Summary
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Detailed Description
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Embolics and drug eluting embolics are being used by interventional radiologists to try and shrink or kill the tumor area.
Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. Subjects were randomized on a 1:1 basis (subjects were blinded to arm they were randomized to).
Post randomization and within four weeks of the first chemoembolization procedure all subjects had a baseline MRI. Following, the first chemoembolization procedure (hqTACE or cTACE) or 'cycle' was completed. Subjects can (per protocol) receive up to 3 TACE cycles. Within 4 weeks after any TACE cycle, an MRI and labs should be conducted/collected to evaluate disease status (reduction vs progression) and measure treated lesions. Any residual disease that is present after after the first TACE will undergo the next TACE cycle (maximum of three). However, if the liver MRI shows a complete response (absence of HCC) then no additional TACE procedures are performed and the subject is followed for survival.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HepaSphere/QuadraSphere TACE
HepaSphere/QuadraSphere TACE
HepaSphere/QuadraSphere Microspheres
HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
Conventional TACE
Conventional TACE
PVA, lipiodol, doxorubicin
Conventional TACE procedure using PVA, lipiodol and doxorubicin
Interventions
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HepaSphere/QuadraSphere Microspheres
HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
PVA, lipiodol, doxorubicin
Conventional TACE procedure using PVA, lipiodol and doxorubicin
Eligibility Criteria
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Inclusion Criteria
2. Patient has signed informed consent
3. Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
i. Histological confirmation ii. Magnetic resonance imaging (MRI) result with early enhancement and delayed enhancement washout of at least one solid liver lesion \> 1 cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.
iii. Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion \> 1cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.
d. Patient must not be suitable for treatment by resection or percutaneous ablation 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:
i. Stage Child-Pugh B 7 ii. Recurrent HCC iii.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
Exclusion Criteria
1. Current or previous treatment with chemo- or radiation therapy or sorafenib
2. Previous treatment with any form of transarterial embolization for HCC
3. Patients with current or history of any other cancer except non-melanomatous skin cancer
4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
5. Performance status ECOG \> 2
6. Child-Pugh scores \>7
7. Active gastrointestinal bleeding
8. Evidence of uncorrectable bleeding diathesis
9. Extra-hepatic spread of the HCC
10. Total Bilirubin \> 3 mg/dL
11. \>50% tumor involvement of the liver
12. Infiltrative or diffuse HCC
13. Encephalopathy not adequately controlled medically
14. Presence of ascites not controlled medically
15. Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G
16. Any contraindication for MRI (eg. metallic implants)
17. Allergy to contrast media that cannot be managed with prophylaxis
18. Allergy to iodized oil
19. Any contraindication to arteriography
20. Any contraindication for doxorubicin administration, including the following:
i. White Blood Cell count (WBC) \<3000 cells/mm₃
ii. Absolute Neutrophil \<1500 cells/mm₃
iii. Cardiac ejection fraction \<50%
iv. Other condition deemed exclusionary by physician
u. Any contraindication for hepatic embolization, including the following:
i. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
ii. Hepatofugal blood flow
iii. Serum creatinine \> 2mg/dL
iv. Uncorrectable impaired clotting
1. Platelet \<50,000/mm₃
2. International Normalized Ratio (INR) \> 1.4
3. Activated Prothrombin Time (aPTT) less than 21 or greater than 40
v. AST \> 5X upper limit of normal for lab
vi. ALT \> 5X upper limit of normal for lab
18 Years
ALL
No
Sponsors
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Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Soulen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Riccardo Lencioni, MD
Role: STUDY_CHAIR
Independent Radiology Panel
Josep Llovet, MD
Role: STUDY_CHAIR
Data Safety Monitoring Board
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Tuscon Medical Center
Tucson, Arizona, United States
Greater Arkansas Veterans Healthcare
Little Rock, Arkansas, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Palo Alto Veterans Institute for Research
Palo Alto, California, United States
Stanford University
Stanford, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Albany Medical Center
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Albert Einstein Healthcare
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
MUSC Medical Center (Medical University of South Carolina)
Charleston, South Carolina, United States
UT Health and Science Center
San Antonio, Texas, United States
University Hospitals K.U. Leuven (Dept of Hematology)
Leuven, , Belgium
Hospital Saint Andre
Bordeaux, , France
Hospital Paul Brousse
Villejuif, , France
Evgenidion University Hospital
Athens, , Greece
S. Croce e Carle Hospital
Cuneo, , Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HCC-P3-11-01
Identifier Type: -
Identifier Source: org_study_id