Surefire Institutional DEB-TACE

Primary Outcome Measures:

• 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
  
  

Secondary Outcome Measures:

• Tumor Assessment via MRI Imaging [ Time Frame: Duration of study (12 months) ]
  Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
  
  
• Tumor Assessment via CT Imaging [ Time Frame: Duration of study (12 months) ]
  Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
  
  
• FACT Hep4 Questionnaire [ Time Frame: Visit 5 (week 5) ]
  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
  
  

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.