Surefire Institutional DEB-TACE

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TACE with Surefire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 a. 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TACE with Surefire<br>Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System. | Procedure: TACE with Surefire<br>* Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Duration of study (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Assessment via MRI Imaging | Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria | 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 | 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 | Visit 5 (week 5) |