Study Stopped
Low enrollment
DEB-TACE for Hepatocellular Carcinoma
QED
Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)
1 other identifier
interventional
170
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Aug 2015
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedJune 21, 2018
June 1, 2018
2.8 years
April 18, 2016
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective tumor response
1 month following initial DEB-TACE procedure
Secondary Outcomes (3)
Objective tumor response
3 months following initial DEB-TACE procedure (or 1 month following retreatment if DEB-TACE retreatment performed)
Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
Procedure
Number of repeat DEB-TACE procedures per lesion
3 months following initial DEB-TACE procedure
Study Arms (2)
DEB-TACE: Standard Endhole Catheter
ACTIVE COMPARATORSubjects will undergo DEB-TACE using a standard endhole catheter.
DEB-TACE: Surefire Infusion System
ACTIVE COMPARATORSubjects will undergo DEB-TACE using the Surefire Infusion System.
Interventions
Transarterial chemoembolization with doxorubicin-eluting beads.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 22, 2016
Study Start
August 1, 2015
Primary Completion
May 15, 2018
Study Completion
June 15, 2018
Last Updated
June 21, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share