Hepatocellular CarcinomaNCT03211598
Surefire Institutional DEB-TACE
A study testing TACE with Surefire in people with Hepatocellular Carcinoma, run by Alexander Kim at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response. 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?
- TACE with Surefire
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Apr 2020
- 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
- Primary liver cancers based on biopsy or imaging criteria
- Child-Pugh A or B7 liver disease
- Bilirubin <2.0 mg/dL
- Albumin >3.0 gm/dL
- ECOG status 0 or 1
- Adequate renal function
Show all 11Show fewer
- Creatinine < 2.0 mg/dL
- Age 18 or older
- Able to understand informed consent
- Life expectancy > 3 months
- Women of childbearing potential must have a negative serum/urine pregnancy test on the day of planned procedure.
Who cannot join
- Portal vein thrombus
- Uncontrolled ascites
- Hepatic encephalopathy
- Uncorrectable coagulopathy (platelets <50,000, INR >1.50)
- Untreatable contrast allergy
- Pregnancy
- Symptomatic congestive heart failure
- Prior systematic therapy for HCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)
The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response.
Read the detailed description
This is a single arm pilot study to evaluate the technical feasibility and safety of performing DEB-TACE using the investigational delivery device: Surefire Infusion System (SIS). Patients presenting with primary liver cancer without evidence of metastatic disease or vascular invasion will be considered for the trial. Patients enrolled in the trial will undergo 1 or 2 sessions of DEB-TACE delivered through SIS as determined by the performing interventional radiologist. Decision for second treatment will be based on the degree of disease burden and vascular anatomy demonstrated on the first treatment session. To limit potential hepatotoxicity, patients with multifocal disease in a single lobe may be treated with a 2nd treatment with the investigational device. Patients with a large lesion being supplied by multiple vessels may also undergo a 2nd treatment session based on the investigator's judgement. The decision to proceed with a second treatment will be determined at the time of the first treatment based on disease burden and vascular anatomy. There will be an interval of 2-4 weeks between treatments. All patients undergoing 2nd treatment will have a repeat laboratory evaluation with treatment deferred for 2-4 weeks for those not meeting initial inclusion criteria. For patients who labs have not normalized at this time will not undergo a 2nd treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE with Surefire
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with SurefireProcedure or surgery
Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System
| Study group | Role | What they receive |
|---|---|---|
| TACE with Surefire | Other | Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System. Receives: Procedure: TACE with Surefire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS.
Assess the technical feasibility of performing TACE using the SIS. If stasis of flow is not reached after 1 vial of DEB, further bland embolization will be performed until stasis is reached or earlier as determined adequate by the treating interventional radiologist.
Measured: During chemoembolization
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assess the safety of SIS for TACE as per CTCAE v 4.03
Measured: Duration of study (12 months)
Secondary outcomes (3)
Tumor Assessment via MRI Imaging
Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
Measured: Duration of study (12 months)
Tumor Assessment via CT Imaging
Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
Measured: Duration of study (12 months)
FACT Hep4 Questionnaire
Correlate outcomes with treatment endpoint, defined as stasis of flow in target vessel on DSA or CBCT, or reflux of particles despite the use of SIS
Measured: Visit 5 (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startOct 2016
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Surefire Medical, Inc.
- Responsible party
- Sponsor-investigator, Alexander Kim, Georgetown University
- Investigators
- Alexander Y Kim, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211598
- Sponsor's protocol ID
- SF Georgetown
- Status last verified
- Jan 2020
- First submitted
- 21 Mar 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee KK, Kim DG, Moon IS, Lee MD, Park JH. Liver transplantation versus liver resection for the treatment of hepatocellular carcinoma. J Surg Oncol. 2010 Jan 1;101(1):47-53. doi: 10.1002/jso.21415.
PubMed 19798686
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)
- ClinicalTrials.gov ID
- NCT03211598
- Acronym / sponsor ID
- SF Georgetown
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alexander KimUniversity, hospital or other
- Collaborators
- Surefire Medical, Inc.
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 7 Jul 2017 (actual)
- 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.
The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response.
Detailed description
This is a single arm pilot study to evaluate the technical feasibility and safety of performing DEB-TACE using the investigational delivery device: Surefire Infusion System (SIS). Patients presenting with primary liver cancer without evidence of metastatic disease or vascular invasion will be considered for the trial. Patients enrolled in the trial will undergo 1 or 2 sessions of DEB-TACE delivered through SIS as determined by the performing interventional radiologist. Decision for second treatment will be based on the degree of disease burden and vascular anatomy demonstrated on the first treatment session. To limit potential hepatotoxicity, patients with multifocal disease in a single lobe may be treated with a 2nd treatment with the investigational device. Patients with a large lesion being supplied by multiple vessels may also undergo a 2nd treatment session based on the investigator's judgement. The decision to proceed with a second treatment will be determined at the time of the first treatment based on disease burden and vascular anatomy. There will be an interval of 2-4 weeks between treatments. All patients undergoing 2nd treatment will have a repeat laboratory evaluation with treatment deferred for 2-4 weeks for those not meeting initial inclusion criteria. For patients who labs have not normalized at this time will not undergo a 2nd treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE with Surefire | Other | Procedure: TACE with SurefireSubjects enrolled in the study will have their TACE procedure with 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 (11 listed)
- Primary liver cancers based on biopsy or imaging criteria
- Child-Pugh A or B7 liver disease
- Bilirubin <2.0 mg/dL
- Albumin >3.0 gm/dL
- ECOG status 0 or 1
Key exclusion criteria (8 listed)
- Portal vein thrombus
- Uncontrolled ascites
- Hepatic encephalopathy
- Uncorrectable coagulopathy (platelets <50,000, INR >1.50)
- Untreatable contrast allergy
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 |
|---|---|---|
| TACE with SurefireSubjects that consent to the study will receive their TACE procedure through the Surefire Infusion System | Procedure or surgery | TACE with Surefire |
Primary outcome
Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS.
Time frame: During chemoembolization
Assess the technical feasibility of performing TACE using the SIS. If stasis of flow is not reached after 1 vial of DEB, further bland embolization will be performed until stasis is reached or earlier as determined adequate by the treating interventional radiologist.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Duration of study (12 months)
Assess the safety of SIS for TACE as per CTCAE v 4.03
3 secondary outcomes
Tumor Assessment via MRI Imaging
Time frame: Duration of study (12 months)
Tumor Assessment via CT Imaging
Time frame: Duration of study (12 months)
FACT Hep4 Questionnaire
Time frame: Visit 5 (week 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 19798686Lee KK, Kim DG, Moon IS, Lee MD, Park JH. Liver transplantation versus liver resection for the treatment of hepatocellular carcinoma. J Surg Oncol. 2010 Jan 1;101(1):47-53. doi: 10.1002/jso.21415.
- Individual participant dataSharing planned: Undecided
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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.
Alexander Y Kim, MD principal investigator
MedStar Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE with Surefire in people with Hepatocellular Carcinoma, run by Alexander Kim at 1 site 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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS. (time frame: During chemoembolization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211598, which also lists 1 linked publication.
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 22 Jan 2020.