The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead

Stopped early · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

This study involves the combined use of the FDA approved device, LC Bead and the FDA approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous malformations. The study is designed to establish if drug eluting beads are more effective and less toxic than standard chemoembolization treatment.

Key facts

Study ID

NCT01259024

Run by

Washington University School of Medicine

People needed

1

Starts

2011-12-01

Expected to finish

2012-04-01

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age > 18
• Patent main portal vein with hepatopetal flow
• Bilirubin less than or equal to 2.5 mg/dl, albumin >2.8g/dl, alkaline phosphatase <630IU/L, AST <235IU/L, ALT <265IU/L, INR <2.0, PTT <40sec., absolute neutrophil count >1K/cumm, platelet count >100K/cumm
• No encephalopathy
• No previous biliary ductal intervention
• Child A status
• Confirmation of Hepatocellular Carcinoma (through biopsy or radiological exam)
• Unresectable HCC and ineligible for possible curative therapies
• Normal ECG with QT <480 msec within the previous 2 months
• Normal MUGA scan within the previous 2 months
• Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)
• Subject is competent and willing to provide written informed consent in order to participate in the study

You may not qualify if…

• Thrombosis or hepatofugal flow in the main portal vein; presence of a large shunt which in the operator's opinion precludes embolization
• Replacement of greater than 50% of the liver parenchyma by tumor
• Bilirubin greater than or equal to 2.6 mg/dl
• ECOG performance status of 2 or greater
• Previous liver directed therapy
• Previous biliary intervention (excluding cholecystectomy)
• Allergy to iodinated contrast used for angiography
• Elevated creatinine greater than or equal to 1.8 mg/dl
• Women who are pregnant or nursing
• Patients in which any of the following are contraindicated: 1)the use of doxorubicin, 2)MRI or CT scans, 3) Hepatic embolization procedures
• Patients with active bacterial or fungal infection that is deemed to be clinically significant by the investigator
• Patients with cardiac disease, including congestive heart failure, recent myocardial infarction, or uncontrolled arrhythmias
• Non-English speaking patients

Where it is running

• Barnes-Jewish Hospital/Washington Univesity School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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