Surefire Institutional DEB-TACE

Alexander Kim

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE with Surefire

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03211598

SF Georgetown

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

TACE with Surefire

Other group

Description:

Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.

Treatment:

Procedure: TACE with Surefire