HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/26/2018
Start Date:April 2011
End Date:December 2022

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Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma

The purpose of this study is to evaluate overall survival in patients treated with
HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with
particle PVA.


Inclusion Criteria:

Patients must meet all of the following inclusion criteria in order to be entered into the
study:

1. Age 18 or older

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:

If patients meet any of the following criteria they may not be entered into the study:

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
We found this trial at
19
sites
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Edward Kim, MD
Phone: 212-241-9369
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Ahmed Kamel, MD
Phone: 205-934-4080
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Clifford Davis, MD
Phone: 813-844-5012
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Albany, New York 12208
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Charleston, South Carolina 29425
Principal Investigator: Marcelo S. Guimares, MD
Phone: 843-876-5544
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303 East Superior Street
Chicago, Illinois 60611
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Little Rock, Arkansas 72205
Principal Investigator: Michael V Beheshti, MD
Phone: 501-257-1743
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Los Angeles, California 90073
Principal Investigator: Hsin-Yi Lee, MD
Phone: 814-744-8252
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Antoinette S Gomes, MD
Phone: 310-794-0376
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Palo Alto, California 94304
Principal Investigator: Rajesh Shah, MD
Phone: 650-723-0728
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Philadelphia, Pennsylvania 19141
Principal Investigator: Paul Brady, MD
Phone: 215-456-6370
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Obaid Shaikh, MD
Phone: 412-360-3653
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San Antonio, Texas 78229
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Daniel Sze, MD
Phone: 650-736-1598
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tucson, Arizona 85711
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Alexander Kim, MD
Phone: 202-444-2047
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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