The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.
University of Minnesota
Minneapolis, Minnesota, United States
Procedure related adverse events
Percentage of adverse events following TACE
Time frame: 1 month
Radiologic Response
mRECIST response after TACE
Time frame: 1 month
Progression free survival
Liver PFS and overall PFS
Time frame: 1, 3, 6, 12, 18, and 24 months
Overall survival
Overall survival
Time frame: 24 months
Change in Model for end stage liver disease (MELD)
Change in MELD (MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43) score at 7 and 30 days post TACE
Time frame: 7 and 30 days
Change in Child Pugh score
Change in Child Pugh score at 7 and 30 days post TACE
Time frame: 7 and 30 days
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