Clinical trial · Interventional
Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE
SPEED 1 Trial: Bridge to Orthotopic Liver Transplantation (OLT) - (Surefire Precision vs Endhole Embolization With DEBTACE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor withdrew funding
Summary
Brief summary (as posted)
The purpose of this study will be to prospectively evaluate the outcomes of patients with hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial chemoembolization) with the Surefire Precision Infusion System for intentional effect of down-staging patients to OLT. Patients with HCC and who are considered candidates for liver transplantation but outside Milancriteria and meet the eligibility criteria will be enrolled in the prospective single arm study. Results of the prospective cohort will be compared to matched historical control patients who were previously treated with DEB-TACE, delivered with standard endhole catheters. This includes all patients treated at the University of Colorado since 2009 treated with 100-300 micron beads for whom follow-up is available.
Conditions
Conditions (2)
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 of the Liver | — | UNRESOLVED | — |
| Subjects Eligible for Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surefire Precision Infusion System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEB-TACE Procedure with Surefire Precision Infusion System
- description
- The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
- interventionNames
- Device: Surefire Precision Infusion System
Primary outcomes (1)
- measure
- Local Recurrence Rate (LRR)
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation and considered for downstaging. * Patients undergoing Surefire DEB-TACE procedure as clinically determined * Single tumor that is \>5 cm and less than 8 cm, OR 1 to 3 tumors with combined diameter greater than 15 cm and less than 24 cm * No portal invasion or extrahepatic spread * No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Preserved liver function (Child-Pugh Class A or B). * Discrete hepatic artery feeding the tumor with vessel diameter \> 1.5 mm Exclusion Criteria: * Advanced bilirubin levels \> 3 mg/dl * AST or ALT\>5 upper limit of normal or \>250 U/l * Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement) * Contraindications for doxorubicin administration. * Child's Class C * Vessels providing flow to the tumor that are less than 1.5 mm in diameter
References
Publications (0)
Data not yet available