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

NCT01387932 | Terminated Phase 3 Results DMC FDA Device

• 1 other identifier: HCC-P3-11-01
• Study Type: interventional
• Target: 235
• Locations: 5 countries
• Sites: 23

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; TACE; HepaSphere Microspheres; QuadraSphere Microspheres; Doxorubicin

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival

  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.

  2 years

Secondary Outcomes (1)

• Objective Response Rates (ORR)

  Study was terminated early so analysis of additional outcome(s) were not possible.

Other Outcomes (1)

• Number of TACE-Related Adverse Events in Subjects Treated With HepaSphere/QuadraSphere vs Subjects Treated With Conventional TACE.

  30 days

Study Arms (2)

HepaSphere/QuadraSphere TACE

EXPERIMENTAL

HepaSphere/QuadraSphere TACE

Device: HepaSphere/QuadraSphere Microspheres

Conventional TACE

ACTIVE COMPARATOR

Conventional TACE

Procedure: PVA, lipiodol, doxorubicin

Interventions

HepaSphere/QuadraSphere Microspheres DEVICE

HepaSphere/QuadraSphere Microspheres loaded with doxorubicin

HepaSphere/QuadraSphere TACE

PVA, lipiodol, doxorubicin PROCEDURE

Conventional TACE procedure using PVA, lipiodol and doxorubicin

Conventional TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Patient has signed informed consent
• 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

You may not qualify if:

• If patients meet any of the following criteria they may not be entered into the study:
• Current or previous treatment with chemo- or radiation therapy or sorafenib
• Previous treatment with any form of transarterial embolization for HCC
• Patients with current or history of any other cancer except non-melanomatous skin cancer
• Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
• Performance status ECOG \> 2
• Child-Pugh scores \>7
• Active gastrointestinal bleeding
• Evidence of uncorrectable bleeding diathesis
• Extra-hepatic spread of the HCC
• Total Bilirubin \> 3 mg/dL
• \>50% tumor involvement of the liver
• Infiltrative or diffuse HCC
• Encephalopathy not adequately controlled medically
• Presence of ascites not controlled medically

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (23)

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

Tuscon Medical Center

Tucson, Arizona, 85711, United States

Location

Greater Arkansas Veterans Healthcare

Little Rock, Arkansas, 72205, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Palo Alto Veterans Institute for Research

Palo Alto, California, 94304, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 35209, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Albert Einstein Healthcare

Philadelphia, Pennsylvania, 19141, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15261, United States

Location

MUSC Medical Center (Medical University of South Carolina)

Charleston, South Carolina, 29425, United States

Location

UT Health and Science Center

San Antonio, Texas, 78229, United States

Location

University Hospitals K.U. Leuven (Dept of Hematology)

Leuven, 3000, Belgium

Location

Hospital Saint Andre

Bordeaux, 33075, France

Location

Hospital Paul Brousse

Villejuif, 94804, France

Location

Evgenidion University Hospital

Athens, 115 28, Greece

Location

S. Croce e Carle Hospital

Cuneo, 12100, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Desmoglein 3; Ethiodized Oil; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides

Limitations and Caveats

Study was terminated early due to insufficient enrolment to support analysis of endpoints. A full safety analysis was completed and is reported.

Results Point of Contact

• Title: Vicky Brunk RN, Vice President, Medical Affairs, Merit Medical
• Organization: Merit Medical Systems, Inc.

vicky.brunk@merit.com

+1 (717) 873-3309

Study Officials

• Michael Soulen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Riccardo Lencioni, MD

  Independent Radiology Panel

  STUDY CHAIR

• Josep Llovet, MD

  Data Safety Monitoring Board

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: July 6, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); GR (1); US (18); IT (1); BE (1)