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

Study Overview
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Brief Summary
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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.

Official Title
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Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin

Conditions
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Hepatocellular Carcinoma, Bilirubinemia

Intervention / Treatment
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* Combination Product: Transarterial chemoembolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transarterial chemoembolization<br>Transarterial chemoembolization | Combination Product: Transarterial chemoembolization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure related adverse events | Percentage of adverse events following TACE | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic Response | mRECIST response after TACE | 1 month | 
| Progression free survival | Liver PFS and overall PFS | 1, 3, 6, 12, 18, and 24 months | 
| Overall survival | Overall survival | 24 months | 
| 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 | 
| Change in Child Pugh score | Change in Child Pugh score at 7 and 30 days post TACE | 7 and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transarterial chemoembolization