Surefire Institutional DEB-TACE
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2018 |
| Start Date: | October 2016 |
| End Date: | December 2019 |
| Contact: | Alexander Y Kim, MD |
| Email: | Alexander.Y.Kim@gunet.georgetown.edu |
| Phone: | 202-444-5478 |
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.
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.
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.
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.
Inclusion Criteria:
1. Primary liver cancers based on biopsy or imaging criteria
2. Child-Pugh A or B7 liver disease
3. Bilirubin <2.0 mg/dL
4. Albumin >3.0 gm/dL
5. ECOG status 0 or 1
6. Adequate renal function
a. Creatinine < 2.0 mg/dL
7. Age 18 or older
8. Able to understand informed consent
9. Life expectancy > 3 months
10. Women of childbearing potential must have a negative serum/urine pregnancy test on the
day of planned procedure.
Exclusion Criteria:
1. Portal vein thrombus
2. Uncontrolled ascites
3. Hepatic encephalopathy
4. Uncorrectable coagulopathy (platelets <50,000, INR >1.50)
5. Untreatable contrast allergy
6. Pregnancy
7. Symptomatic congestive heart failure
8. Prior systematic therapy for HCC
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