Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota; University of Minnesota
• Treatments: Doxorubicin; Ethanol; Ethiodized Oil; Glucuronyl glucosamine glycan sulfate; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Child-Pugh class A or B

• Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria

• Patient not a candidate for surgical resection or percutaneous ablation

• age > 18 years old and able to consent

Exclusion Criteria:

• Child-Pugh class C

• Model for End-Stage Liver Disease (MELD) score >16

• Extrahepatic disease

• Bilateral or main portal vein thrombus

• Total bilirubin > 2.2

• Serum albumin < 2.6

• Life expectancy < 2 months

• Uncorrected INR > 2

• Eastern Cooperative Oncology Group (ECOG) status > 2

• Tumor burden > 50% liver volume

• Hepatofugal portal venous flow