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

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03259581
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Bilirubinemia	Combination Product: Transarterial chemoembolization	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transarterial chemoembolization 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.

Outcome Measures

Primary Outcome Measures

1. Procedure related adverse events [1 month]

   Percentage of adverse events following TACE

Secondary Outcome Measures

1. Radiologic Response [1 month]

   mRECIST response after TACE

2. Progression free survival [1, 3, 6, 12, 18, and 24 months]

   Liver PFS and overall PFS

3. Overall survival [24 months]

   Overall survival

4. 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

5. Change in Child Pugh score [7 and 30 days]

   Change in Child Pugh score at 7 and 30 days post TACE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03259581
• Other Study ID Numbers: 2016LS137
• First Posted: Aug 23, 2017
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• 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
• Keywords provided by University of Minnesota: transarterial chemoembolization
• Additional relevant MeSH terms: Hyperbilirubinemia

Study Results

No Results Posted as of Mar 21, 2022