Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hepatocellular-carcinoma
Started Jan 2018
Typical duration for phase_1 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 21, 2022
March 1, 2022
4 years
August 1, 2017
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedure related adverse events
Percentage of adverse events following TACE
1 month
Secondary Outcomes (5)
Radiologic Response
1 month
Progression free survival
1, 3, 6, 12, 18, and 24 months
Overall survival
24 months
Change in Model for end stage liver disease (MELD)
7 and 30 days
Change in Child Pugh score
7 and 30 days
Study Arms (1)
Transarterial chemoembolization
EXPERIMENTALTransarterial chemoembolization
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 23, 2017
Study Start
January 2, 2018
Primary Completion
December 31, 2021
Study Completion
February 1, 2022
Last Updated
March 21, 2022
Record last verified: 2022-03