Clinical trial NCT03170869: Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE
Official title: SPEED 1 Trial: Bridge to Orthotopic Liver Transplantation (OLT) - (Surefire Precision vs Endhole Embolization With DEBTACE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma of the Liver
Subjects Eligible for Liver Transplantation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Surefire Medical, Inc.
First posted: 2017-05-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fifty (50) subjects will be enrolled in the prospective arm.
Primary purpose: TREATMENT

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.

Detailed description: This is a single institution prospective clinical trial with historical matched controls. This protocol standardizes DEB-TACE delivery with the Surefire Precision Infusion System. This protocol does not change patient therapy. All patient safety monitoring, treatment procedures and follow-up procedures will be performed in accordance with standard clinical practice.

Fifty (50) subjects will be enrolled in the prospective arm. Data from one hundred (100) historical randomly sampled control subjects (1:2 ratio) will be selected.

Subjects will be followed at 1 week, 1 month, 3 months, then every 3 months, following the initial DEB-TACE procedure until the subject receives a liver transplant or death. The study will be concluded upon completion of enrollment and follow-up of the 50 patients. It is estimated that the time to complete patient enrollment and follow-up is 24 months. The estimated date for study completion (complete primary analyses) is June 2018. This is based on the average survival vs. time to transplant at this center. If there are individual patients that extend beyond this period the time may be slightly extended.

Eligibility criteria: 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

Primary outcomes:
measure: Local Recurrence Rate (LRR)
timeFrame: 6 months
Secondary outcomes:
measure: Tumor Response
timeFrame: 6 months
measure: Time to Progression
timeFrame: Every 3 months through 24 months
measure: Survival Time
timeFrame: Every 3 months through 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David T Johnson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: