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

Hepatocellular Carcinoma Clinical Trial

Official title:

Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259581
• Other study ID #: 2016LS137
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bilirubinemia
• Hepatocellular Carcinoma
• Hyperbilirubinemia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure related adverse events	Percentage of adverse events following TACE	1 month
Secondary	Radiologic Response	mRECIST response after TACE	1 month
Secondary	Progression free survival	Liver PFS and overall PFS	1, 3, 6, 12, 18, and 24 months
Secondary	Overall survival	Overall survival	24 months
Secondary	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
Secondary	Change in Child Pugh score	Change in Child Pugh score at 7 and 30 days post TACE	7 and 30 days