Clinical trial · Interventional
DEB-TACE for Hepatocellular Carcinoma
Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DEB-TACE: Standard Endhole Catheter
- description
- Subjects will undergo DEB-TACE using a standard endhole catheter.
- interventionNames
- Procedure: DEB-TACE
- type
- ACTIVE_COMPARATOR
- label
- DEB-TACE: Surefire Infusion System
- description
- Subjects will undergo DEB-TACE using the Surefire Infusion System.
- interventionNames
- Procedure: DEB-TACE
Primary outcomes (1)
- measure
- Objective tumor response
- timeFrame
- 1 month following initial DEB-TACE procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available