Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin

Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin

The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Bilirubinemia
• Intervention / Treatment: Combination product: Transarterial chemoembolization

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• hepatocellular carcinoma (HCC)
• Direct or conjugated bilirubin < 3 mg/dl
• Total bilirubin > 3 mg/dl
• Willing and able to provide informed consent
• >18 years of age

Exclusion Criteria:

• Currently pregnant
• Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
• Arterial anatomy which would preclude selective transarterial chemoembolization
• Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
• Patients with extrahepatic metastases
• Patients with portal vein invasion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transarterial chemoembolization	Combination product: Transarterial chemoembolization; Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related adverse events	Percentage of adverse events following TACE	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	24 months
Radiologic Response	mRECIST response after TACE	1 month
Progression free survival	Liver PFS and overall PFS	1, 3, 6, 12, 18, and 24 months
Change in Model for end stage liver disease (MELD)	Change in MELD (MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43) score at 7 and 30 days post TACE	7 and 30 days
Change in Child Pugh score	Change in Child Pugh score at 7 and 30 days post TACE	7 and 30 days

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: transarterial chemoembolization
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperbilirubinemia
• Other Study ID Numbers: 2016LS137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes