A Phase 1 interventional study of Transarterial chemoembolization in Hepatocellular Carcinoma and Bilirubinemia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by University of Minnesota · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Transarterial chemoembolization
Combination Product: Transarterial chemoembolization
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.
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
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Minnesota