Primary Outcome Measures:
- Objective tumor response [ Time Frame: 6 months following initial DEB-TACE procedure. ]
Secondary Outcome Measures:
- Objective tumor response [ Time Frame: 1 and 3 months following initial DEB-TACE procedure ]
- Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s) [ Time Frame: 6 months following initial DEB-TACE procedure ]
- Tumor characteristics [ Time Frame: DEB-TACE procedure(s) ]
Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)
- Size of doxorubicin-eluting beads used during DEB-TACE procedure(s) [ Time Frame: DEB-TACE procedure(s) ]
- Changes in alpha-fetoprotein (AFP) blood levels [ Time Frame: 1, 3 and 6 months following initial DEB-TACE procedure ]
Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). The best results for cTACE occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.
DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.