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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	17 May 2021
Main ID:	NCT01387932
Date of registration:	11/04/2011
Prospective Registration:	Yes
Primary sponsor:	Merit Medical Systems, Inc.
Public title:	HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer HiQuality
Scientific title:	Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma
Date of first enrolment:	June 2011
Target sample size:	235
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT01387932
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Austria	Belgium	Egypt	France	Greece	Italy	United States

Contacts

Name:	Josep Llovet, MD
Address:
Telephone:
Email:
Affiliation:	Data Safety Monitoring Board

Name:	Riccardo Lencioni, MD
Address:
Telephone:
Email:
Affiliation:	Independent Radiology Panel

Name:	Michael Soulen, MD
Address:
Telephone:
Email:
Affiliation:	University of Pennsylvania

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

Device: HepaSphere/QuadraSphere Microspheres

Procedure: PVA, lipiodol, doxorubicin

Primary Outcome(s)

Median overall survival [Time Frame: 2 years]

Secondary Outcome(s)

ORR in the treated area [Time Frame: Approx 6 months]

Resource utilization [Time Frame: Approx 6 months]

Objective Response Rates (ORR) [Time Frame: Approx 6 months]

Adverse Events [Time Frame: Approx 6 months]

Secondary ID(s)

HCC-P3-11-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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