Back to resultsSafety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
Primary Purpose
Hepatocellular Carcinoma, Bilirubinemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transarterial chemoembolization
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring transarterial chemoembolization
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transarterial chemoembolization
Arm Description
Transarterial chemoembolization
Outcomes
Primary Outcome Measures
Procedure related adverse events
Percentage of adverse events following TACE
Secondary Outcome Measures
Radiologic Response
mRECIST response after TACE
Progression free survival
Liver PFS and overall PFS
Overall survival
Overall survival
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
Change in Child Pugh score
Change in Child Pugh score at 7 and 30 days post TACE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03259581
Brief Title
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
Official Title
Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Bilirubinemia
Keywords
transarterial chemoembolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transarterial chemoembolization
Arm Type
Experimental
Arm Description
Transarterial chemoembolization
Intervention Type
Combination Product
Intervention Name(s)
Transarterial chemoembolization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedure related adverse events
Description
Percentage of adverse events following TACE
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Radiologic Response
Description
mRECIST response after TACE
Time Frame
1 month
Title
Progression free survival
Description
Liver PFS and overall PFS
Time Frame
1, 3, 6, 12, 18, and 24 months
Title
Overall survival
Description
Overall survival
Time Frame
24 months
Title
Change in Model for end stage liver disease (MELD)
Description
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
Time Frame
7 and 30 days
Title
Change in Child Pugh score
Description
Change in Child Pugh score at 7 and 30 days post TACE
Time Frame
7 and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
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