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

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma; Bilirubinemia
• Interventions: Combination Product: Transarterial chemoembolization

• Registration Number: NCT03259581
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-23
• Study Start: 2018-01-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transarterial chemoembolization	Transarterial chemoembolization	Transarterial chemoembolization

Primary Outcome Measures

Name	Time	Method
Procedure related adverse events	1 month	Percentage of adverse events following TACE

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months	Overall survival
Radiologic Response	1 month	mRECIST response after TACE
Change in Child Pugh score	7 and 30 days	Change in Child Pugh score at 7 and 30 days post TACE
Change in Model for end stage liver disease (MELD)	7 and 30 days	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
Progression free survival	1, 3, 6, 12, 18, and 24 months	Liver PFS and overall PFS

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States