DEB-TACE for Hepatocellular Carcinoma

Stopped early · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy drug, doxorubicin, and delivered to the tumor through an arterial catheter. The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also causes arterial embolization, the process in which a blood vessel is blocked. Treatment of HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the cancer in order to meet the criteria which may allow patients to become candidates for liver transplantation. The purpose of this study is to compare tumor response and medical outcomes for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion System.

Key facts

Study ID

NCT02748161

Run by

Surefire Medical, Inc.

People needed

170

Starts

2015-08-01

Expected to finish

2018-06-15

Last updated by the study team

2018-06-21

Who can join

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

You may qualify if…

• Patients aged 18 years or older, inclusive
• Diagnosis of HCC
• Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
• No portal invasion or extrahepatic spread on imaging.
• Child-Pugh Class A or B.
• No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.

You may not qualify if…

• Bilirubin levels greater than 3 mg/dl
• AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
• Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement).
• Contraindications for doxorubicin administration.
• Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
• Unable or unwilling to provide informed consent.
• Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
• Women who are pregnant or breast feeding.
• Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
• Portal vein thrombosis of bland or malignant origin.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• USC — Los Angeles, California, United States
• Radiology Imaging Associates — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Maryland — Baltimore, Maryland, United States
• New York University — New York, New York, United States
• Cleveland Clinical Foundation — Cleveland, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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