Hepatocellular CarcinomaQEDNCT02748161
DEB-TACE for Hepatocellular Carcinoma
A study testing DEB-TACE in people with Hepatocellular Carcinoma, run by Surefire Medical, Inc. at 11 sites in United States.
Trial summary
Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization (DEB-TACE). 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?
- DEB-TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2015to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 aged 18 years or older, inclusive
- Diagnosis of HCC
- Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
- No portal invasion or extrahepatic spread on imaging.
- Child-Pugh Class A or B.
- No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.
Who cannot join
- Bilirubin levels greater than 3 mg/dl
- AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
- Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement).
- Contraindications for doxorubicin administration.
- Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
- Unable or unwilling to provide informed consent.
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- Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
- Women who are pregnant or breast feeding.
- Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
- Portal vein thrombosis of bland or malignant origin.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Cleveland Clinical Foundation
Cleveland, Ohio
University Hospitals of Cleveland
Cleveland, Ohio
Radiology Imaging Associates
Denver, Colorado
UCLA
Los Angeles, California
USC
Los Angeles, California
New York University
New York, New York
University of Arizona
Phoenix, Arizona
University of Utah
Salt Lake City, Utah
Georgetown University
Washington D.C., District of Columbia
About this study
Official title: Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)
Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy drug, doxorubicin, and delivered to the tumor through an arterial catheter.
The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also causes arterial embolization, the process in which a blood vessel is blocked. Treatment of HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the cancer in order to meet the criteria which may allow patients to become candidates for liver transplantation. The purpose of this study is to compare tumor response and medical outcomes for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion System.
Read the detailed description
Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). TACE with doxorubicin-eluting beads (DEB-TACE) is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE and studies have documented its safety and efficacy. DEB-TACE is currently utilized for: (1) patients who have unresectable HCC; and (2) patients who meet the Milan Criteria and currently on liver transplantation lists.
The biggest challenge for these procedures has been the inability to actually quantify embolization in a real-time setting to provide immediate feedback to the operator. Although various methods, such as perfusion analysis with CT or MRI, have been described, these require advanced imaging equipment/capabilities, extensive post processing analysis, and can create challenging workflows.
Currently the best results occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by CT has been shown to have improved outcomes. However, with standard endhole catheters achieving maximum delivery of embolic agents is limited by the development of stasis and subsequent non-target injury.
As DEB-TACE is performed through an endhole catheter with either stasis or substasis as an endpoint. The current methodology is extremely subjective, lacks a quantifiable endpoint, and results in various degrees of embolization on patients. Often this can result in repeat procedures or the progression of tumor.
Recently, there has been FDA clearance of a new anti-reflux catheter, Surefire® Infusion System (SIS, Westminster, CO). The current design has an expandable tip which collapses during forward flow, and then dynamically seal off the vessel with reversal of flow, analogous to a valve. SIS, with its expandable tip microcatheter, has been demonstrated clinically to cause a slight decrease in intra-arterial pressure in the antegrade, or downstream, vascular compartment. Although this device was designed primarily to prevent retrograde reflux of embolic agents, the downstream blood pressure reduction may serve as a biomarker on quantifying embolization.
The goal is to develop a method that: (1) allows maximum delivery of embolic spheres into the tumor tissue to stasis without reflux; (2) enables direct real time numerical quantification on the degree of embolization; and (3) provides an intra-procedural functional parameter which could be used to guide the optimal therapeutic endpoints at the time of treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB-TACE
- Keywords
- Hepatocellular carcinoma, DEB-TACE, QED
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACEProcedure or surgery
Transarterial chemoembolization with doxorubicin-eluting beads.
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE: Standard Endhole Catheter | Active comparator | Subjects will undergo DEB-TACE using a standard endhole catheter. Receives: Procedure: DEB-TACE |
| DEB-TACE: Surefire Infusion System | Active comparator | Subjects will undergo DEB-TACE using the Surefire Infusion System. Receives: Procedure: DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response
Measured: 1 month following initial DEB-TACE procedure
Secondary outcomes (3)
Objective tumor response
Measured: 3 months following initial DEB-TACE procedure (or 1 month following retreatment if DEB-TACE retreatment performed)
Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
Measured: Procedure
Number of repeat DEB-TACE procedures per lesion
Measured: 3 months following initial DEB-TACE procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startAug 2015
- Primary completion15 May 2018
- Study completion15 Jun 2018
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surefire Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748161
- Sponsor's protocol ID
- HP-00061366
- Acronym
- QED
- Status last verified
- Jun 2018
- First submitted
- 18 Apr 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)
- ClinicalTrials.gov ID
- NCT02748161
- Acronym / sponsor ID
- QED / HP-00061366
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, DEB-TACE, QED
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Surefire Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy drug, doxorubicin, and delivered to the tumor through an arterial catheter.
The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also causes arterial embolization, the process in which a blood vessel is blocked. Treatment of HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the cancer in order to meet the criteria which may allow patients to become candidates for liver transplantation. The purpose of this study is to compare tumor response and medical outcomes for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion System.
Detailed description
Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). TACE with doxorubicin-eluting beads (DEB-TACE) is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE and studies have documented its safety and efficacy. DEB-TACE is currently utilized for: (1) patients who have unresectable HCC; and (2) patients who meet the Milan Criteria and currently on liver transplantation lists.
The biggest challenge for these procedures has been the inability to actually quantify embolization in a real-time setting to provide immediate feedback to the operator. Although various methods, such as perfusion analysis with CT or MRI, have been described, these require advanced imaging equipment/capabilities, extensive post processing analysis, and can create challenging workflows.
Currently the best results occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by CT has been shown to have improved outcomes. However, with standard endhole catheters achieving maximum delivery of embolic agents is limited by the development of stasis and subsequent non-target injury.
As DEB-TACE is performed through an endhole catheter with either stasis or substasis as an endpoint. The current methodology is extremely subjective, lacks a quantifiable endpoint, and results in various degrees of embolization on patients. Often this can result in repeat procedures or the progression of tumor.
Recently, there has been FDA clearance of a new anti-reflux catheter, Surefire® Infusion System (SIS, Westminster, CO). The current design has an expandable tip which collapses during forward flow, and then dynamically seal off the vessel with reversal of flow, analogous to a valve. SIS, with its expandable tip microcatheter, has been demonstrated clinically to cause a slight decrease in intra-arterial pressure in the antegrade, or downstream, vascular compartment. Although this device was designed primarily to prevent retrograde reflux of embolic agents, the downstream blood pressure reduction may serve as a biomarker on quantifying embolization.
The goal is to develop a method that: (1) allows maximum delivery of embolic spheres into the tumor tissue to stasis without reflux; (2) enables direct real time numerical quantification on the degree of embolization; and (3) provides an intra-procedural functional parameter which could be used to guide the optimal therapeutic endpoints at the time of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE: Standard Endhole Catheter | Active comparator | Procedure: DEB-TACESubjects will undergo DEB-TACE using a standard endhole catheter. |
| DEB-TACE: Surefire Infusion System | Active comparator | Procedure: DEB-TACESubjects will undergo DEB-TACE using the Surefire Infusion System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 years or older, inclusive
- Diagnosis of HCC
- Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
- No portal invasion or extrahepatic spread on imaging.
- Child-Pugh Class A or B.
Key exclusion criteria (10 listed)
- Bilirubin levels greater than 3 mg/dl
- AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
- Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement).
- Contraindications for doxorubicin administration.
- Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
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 |
|---|---|---|
| DEB-TACETransarterial chemoembolization with doxorubicin-eluting beads. | Procedure or surgery | DEB-TACE: Standard Endhole Catheter, DEB-TACE: Surefire Infusion System |
Primary outcome
Objective tumor response
Time frame: 1 month following initial DEB-TACE procedure
3 secondary outcomes
Objective tumor response
Time frame: 3 months following initial DEB-TACE procedure (or 1 month following retreatment if DEB-TACE retreatment performed)
Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
Time frame: Procedure
Number of repeat DEB-TACE procedures per lesion
Time frame: 3 months following initial DEB-TACE procedure
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB-TACE in people with Hepatocellular Carcinoma, run by Surefire Medical, Inc. at 11 sites in United States.
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 8 inclusion and 10 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Objective tumor response (time frame: 1 month following initial DEB-TACE procedure). 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 21 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.