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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01387932
Recruitment Status : Terminated (The clinical study was terminated due to the inability to meet target enrollment.)
First Posted : July 6, 2011
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Brief Summary:
The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: HepaSphere/QuadraSphere Microspheres Procedure: PVA, lipiodol, doxorubicin Phase 3

Detailed Description:

This phase three, interventional, and prospective study consists of a patient population that has advanced liver cancer (hepatocellular cancer [HCC]) that cannot be removed by standard therapies such as surgical removal, liver transplant, and/or ablation.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized 1:1 to receive either 1. A Conventional TACE (Trans Arterial Chemoembolization) procedure using PVA, lipiodol and doxorubicin (cTACE), or 2. HepaSphere/QuadraSphere Microspheres loaded with doxorubicin for Trans Arterial Chemoembolization (hqTACE). Participants in both treatment arms will be followed for overall survival, the primary study endpoint.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants are blinded to the treatment they are randomized to (cTACE or hqTACE). Central Reviewers (two interventional radiologists) will evaluate study participant's liver MRIs to assess the tumor response. The Central Reviewers will be blinded to the treatment the participant received.
Primary Purpose: Treatment
Official Title: Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma
Actual Study Start Date : June 2011
Actual Primary Completion Date : February 2021
Actual Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HepaSphere/QuadraSphere TACE
HepaSphere/QuadraSphere TACE
Device: HepaSphere/QuadraSphere Microspheres
HepaSphere/QuadraSphere Microspheres loaded with doxorubicin

Active Comparator: Conventional TACE
Conventional TACE
Procedure: PVA, lipiodol, doxorubicin
Conventional TACE procedure using PVA, lipiodol and doxorubicin

Primary Outcome Measures :
  1. Median Overall Survival [ Time Frame: 2 years ]
    Median overall survival will be calculated using the Intent-to-Treat (ITT) population in each treatment arm when the last subject has completed two years of follow up after their first study TACE procedure. Per protocol, study subjects were followed for survival until death or deemed lost to follow up. All deaths are reported within safety.

Secondary Outcome Measures :
  1. Objective Response Rates (ORR) [ Time Frame: Study was terminated early so analysis of additional outcome(s) were not possible. ]
    The Objective Response Rate will be calculated for the ITT population by adding the number of participants that were determined to have complete or partial response (utilizing mRECIST criteria) and dividing by the number of ITT participants.

Other Outcome Measures:
  1. Number of TACE-Related Adverse Events in Subjects Treated With HepaSphere/QuadraSphere vs Subjects Treated With Conventional TACE. [ Time Frame: 30 days ]

    The number of TACE- Related adverse events experienced by subjects treated with HepaSphere/QuadraSphere will be compared to the number of TACE-related adverse events experienced by subjects treated with conventional TACE.

    Adverse events were recorded for treated subjects from the date of randomization up to and including 30 days post the last study MRI.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387932

Show Show 23 study locations
Sponsors and Collaborators
Merit Medical Systems, Inc.
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Principal Investigator: Michael Soulen, MD University of Pennsylvania
Study Chair: Riccardo Lencioni, MD Independent Radiology Panel
Study Chair: Josep Llovet, MD Data Safety Monitoring Board
  Study Documents (Full-Text)

Documents provided by Merit Medical Systems, Inc.:
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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01387932    
Other Study ID Numbers: HCC-P3-11-01
First Posted: July 6, 2011    Key Record Dates
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Merit Medical Systems, Inc.:
Hepatocellular carcinoma
HepaSphere Microspheres
QuadraSphere Microspheres
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action