A Clinical Study of Precision TACE (P-TACE) With Surefire

Withdrawn before enrolling · Not applicable

Conditions studied: Unresectable Hepatocellular Carcinoma

In brief

The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).

Key facts

Study ID

NCT03345225

Run by

University of Miami

People needed

0

Starts

2018-05-01

Expected to finish

2021-11-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
• Barcelona Clinic Liver Cancer Classification (BCLC) A or B
• Child-Pugh Class A or B
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• 1 to 5 target tumors that are < 6cm with at least one tumor ≥ 3cm in size
• Vessel size ≥ 1.5 mm
• Subject must be able to provide written informed consent

You may not qualify if…

• Extra-hepatic spread of the cancer
• Macrovascular tumor invasion
• Diffuse HCC (>50% liver involvement)
• Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
• Advanced liver disease (bilirubin > 3 mg/dl, aspartate aminotransferase (AST) or ALT > 5x upper limit of normal or > 250 U/I
• Extrahepatic supply to the tumor
• Hypovascular tumors
• Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
• Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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