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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merit Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01387932
First received: April 11, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Merit Medical Systems, Inc.:

Primary Outcome Measures:
  • Median overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rates (ORR) [ Time Frame: Approx 6 months ] [ Designated as safety issue: No ]
  • ORR in the treated area [ Time Frame: Approx 6 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Approx 6 months ] [ Designated as safety issue: Yes ]
  • Resource utilization [ Time Frame: Approx 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: April 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387932

Contacts
Contact: HiQuality Study HiQuality@merit.com

  Show 26 Study Locations
Sponsors and Collaborators
Merit Medical Systems, Inc.
Investigators
Principal Investigator: Michael Soulen, MD University of Pennsylvania
Study Chair: Riccardo Lencioni, MD Independent Radiologoy Panel
Study Chair: Josep Llovet, MD Data Safety Monitoring Board
  More Information

No publications provided

Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01387932     History of Changes
Other Study ID Numbers: HCC-P3-11-01
Study First Received: April 11, 2011
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Merit Medical Systems, Inc.:
Hepatocellular carcinoma
TACE
HepaSphere Microspheres
QuadraSphere Microspheres
Doxorubicin

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014