Hepatocellular CarcinomaPhase 3HiQualityNCT01387932
HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
A Phase 3 study testing HepaSphere/QuadraSphere Microspheres and PVA, lipiodol, doxorubicin in people with Hepatocellular Carcinoma, run by Merit Medical Systems, Inc. at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HepaSphere/QuadraSphere Microspheres and PVA, lipiodol, doxorubicin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Jun 2011to Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
- 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:
- 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.
- 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.
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- 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
- Patient MUST meet at least ONE of the following criteria:
- Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1
- Patient has a life expectancy of at least 6 months
- Absence of occlusive thrombus to the main portal trunk
Who cannot join
- 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
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- 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
- Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G
- Any contraindication for MRI (eg. metallic implants)
- Allergy to contrast media that cannot be managed with prophylaxis
- Allergy to iodized oil
- Any contraindication to arteriography
- Any contraindication for doxorubicin administration, including the following:
- White Blood Cell count (WBC) <3000 cells/mm₃
- Absolute Neutrophil <1500 cells/mm₃
- Cardiac ejection fraction <50%
- Other condition deemed exclusionary by physician
- Any contraindication for hepatic embolization, including the following:
- Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
- Hepatofugal blood flow
- Serum creatinine > 2mg/dL
- Uncorrectable impaired clotting
- Platelet <50,000/mm₃
- International Normalized Ratio (INR) > 1.4
- Activated Prothrombin Time (aPTT) less than 21 or greater than 40
- AST > 5X upper limit of normal for lab
- ALT > 5X upper limit of normal for lab
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States18 sites
Albany Medical Center
Albany, New York, 12208
University of Alabama at Birmingham
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 35209
MUSC Medical Center (Medical University of South Carolina)
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Greater Arkansas Veterans Healthcare
Little Rock, Arkansas, 72205
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
UCLA
Los Angeles, California, 90095
Mount Sinai Medical Center
New York, New York, 10029
Palo Alto Veterans Institute for Research
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Albert Einstein Healthcare
Philadelphia, Pennsylvania, 19141
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15261
UT Health and Science Center
San Antonio, Texas, 78229
Stanford University
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
Tuscon Medical Center
Tucson, Arizona, 85711
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
France2 sites
Hospital Saint Andre
Bordeaux, 33075
Hospital Paul Brousse
Villejuif, 94804
Belgium1 site
University Hospitals K.U. Leuven (Dept of Hematology)
Leuven, 3000
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HepaSphere/QuadraSphere Microspheres, PVA, lipiodol, doxorubicin
- Keywords
- Hepatocellular carcinoma, TACE, HepaSphere Microspheres, QuadraSphere Microspheres, Doxorubicin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaSphere/QuadraSphere MicrospheresDevice
HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
PVA, lipiodol, doxorubicinProcedure or surgery
Conventional TACE procedure using PVA, lipiodol and doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| HepaSphere/QuadraSphere TACE | Experimental | HepaSphere/QuadraSphere TACE Receives: Device: HepaSphere/QuadraSphere Microspheres |
| Conventional TACE | Active comparator | Conventional TACE Receives: Procedure: PVA, lipiodol, doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Objective Response Rates (ORR)
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.
Measured: Study was terminated early so analysis of additional outcome(s) were not possible.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2021
- Study completionFeb 2021
Why it stopped: The clinical study was terminated due to the inability to meet target enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Soulen, MD, Principal investigator, University of PennsylvaniaRiccardo Lencioni, MD, Study chair, Independent Radiology PanelJosep Llovet, MD, Study chair, Data Safety Monitoring Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387932
- Sponsor's protocol ID
- HCC-P3-11-01
- Acronym
- HiQuality
- Status last verified
- Nov 2021
- First submitted
- 11 Apr 2011
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01387932
- Acronym / sponsor ID
- HiQuality / HCC-P3-11-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, TACE, HepaSphere Microspheres, QuadraSphere Microspheres, Doxorubicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study was terminated due to the inability to meet target enrollment.
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HepaSphere/QuadraSphere TACE | Experimental | Device: HepaSphere/QuadraSphere MicrospheresHepaSphere/QuadraSphere TACE |
| Conventional TACE | Active comparator | Procedure: PVA, lipiodol, doxorubicinConventional TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
- 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:
- 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.
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepaSphere/QuadraSphere MicrospheresHepaSphere/QuadraSphere Microspheres loaded with doxorubicin | Device | HepaSphere/QuadraSphere TACE |
| PVA, lipiodol, doxorubicinConventional TACE procedure using PVA, lipiodol and doxorubicin | Procedure or surgery | Conventional TACE |
Primary outcome
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.
1 secondary outcome
Objective Response Rates (ORR)
Time frame: Study was terminated early so analysis of additional outcome(s) were not possible.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Soulen, MD principal investigator
University of Pennsylvania
Riccardo Lencioni, MD study chair
Independent Radiology Panel
Josep Llovet, MD study chair
Data Safety Monitoring Board
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HepaSphere/QuadraSphere Microspheres and PVA, lipiodol, doxorubicin in people with Hepatocellular Carcinoma, run by Merit Medical Systems, Inc. at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Belgium, Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.