Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE

NCT03170869 | Terminated Results DMC FDA Device

• 1 other identifier: 16-1313.cc
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma of the Liver; Subjects Eligible for Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Local Recurrence Rate (LRR)

  For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test.

  6 months

Secondary Outcomes (3)

• Tumor Response

  6 months

• Time to Progression

  Every 3 months through 24 months

• Survival Time

  Every 3 months through 24 months

Study Arms (1)

DEB-TACE Procedure with Surefire Precision Infusion System

EXPERIMENTAL

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.

Device: Surefire Precision Infusion System

Interventions

Surefire Precision Infusion System DEVICE

All patients enrolled in this protocol will receive DEB-TACE, which is the standard of care prescribed by their physician. Standard 5 Fr and 3 Fr catheters will be used to perform diagnostic angiography to map the hepatic vasculature to the tumor. Using standard technique, the target vessel feeding the tumor will be catheterized and DEB-TACE administered using the Surefire Precision catheter. The Doxorubicin dosing used in the DEB-TACE will be based upon tumor volume. DEB-TACE will be administered until the first of the following endpoints are reached: Achievement of target dose with stasis, leeching of contrast through the expandable tip and development of distal intrahepatic collaterals.

DEB-TACE Procedure with Surefire Precision Infusion System

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Surefire Medical, Inc.: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Limitations and Caveats

Zero participants were analyzed as the study was terminated early due to change in funding. No statistical analysis was performed.

Results Point of Contact

• Title: Dr. Thor Johnson
• Organization: University of Colorado

thor.johnson@ucdenver.edu

720-848-1765

Study Officials

• David T Johnson, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fifty (50) subjects will be enrolled in the prospective arm.

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: April 12, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)