Clinical trial · Interventional
A Clinical Study of Precision TACE (P-TACE) With Surefire
A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
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).
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 |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Endhole Microcatheter | Device | — | UNRESOLVED |
| SureFire Infusion System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter
- interventionNames
- Device: Standard Endhole Microcatheter
- type
- EXPERIMENTAL
- label
- Surefire Group
- description
- Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System
- interventionNames
- Device: SureFire Infusion System
Primary outcomes (1)
- measure
- Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy 2. Barcelona Clinic Liver Cancer Classification (BCLC) A or B 3. Child-Pugh Class A or B 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. 1 to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size 6. Vessel size ≥ 1.5 mm 7. Subject must be able to provide written informed consent Exclusion Criteria: 1. Extra-hepatic spread of the cancer 2. Macrovascular tumor invasion 3. Diffuse HCC (\>50% liver involvement) 4. Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s) 5. Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I 6. Extrahepatic supply to the tumor 7. Hypovascular tumors 8. Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent 9. Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.
References
Publications (0)
Data not yet available