<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259581</url>
  </required_header>
  <id_info>
    <org_study_id>2016LS137</org_study_id>
    <nct_id>NCT03259581</nct_id>
  </id_info>
  <brief_title>Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin</brief_title>
  <official_title>Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the safety of selective transarterial chemoembolization&#xD;
      (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but&#xD;
      relatively normal direct bilirubin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure related adverse events</measure>
    <time_frame>1 month</time_frame>
    <description>Percentage of adverse events following TACE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiologic Response</measure>
    <time_frame>1 month</time_frame>
    <description>mRECIST response after TACE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>1, 3, 6, 12, 18, and 24 months</time_frame>
    <description>Liver PFS and overall PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Model for end stage liver disease (MELD)</measure>
    <time_frame>7 and 30 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Pugh score</measure>
    <time_frame>7 and 30 days</time_frame>
    <description>Change in Child Pugh score at 7 and 30 days post TACE</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Bilirubinemia</condition>
  <arm_group>
    <arm_group_label>Transarterial chemoembolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transarterial chemoembolization</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Transarterial chemoembolization</intervention_name>
    <description>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.</description>
    <arm_group_label>Transarterial chemoembolization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  Direct or conjugated bilirubin &lt; 3 mg/dl&#xD;
&#xD;
          -  Total bilirubin &gt; 3 mg/dl&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Patients who are surgical or ablation candidates as determined by multidisciplinary&#xD;
             hepatobiliary tumor conference.&#xD;
&#xD;
          -  Arterial anatomy which would preclude selective transarterial chemoembolization&#xD;
&#xD;
          -  Patients who have a INR or platelet count which are not correctable to &lt;1.8 and&#xD;
             &gt;35,000 respectively&#xD;
&#xD;
          -  Patients with extrahepatic metastases&#xD;
&#xD;
          -  Patients with portal vein invasion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transarterial chemoembolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperbilirubinemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259581
org study id: 2016LS137
nct id: NCT03259581
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedure related adverse events
time frame: 1 month
description: Percentage of adverse events following TACE
measure: Radiologic Response
time frame: 1 month
description: mRECIST response after TACE
measure: Progression free survival
time frame: 1, 3, 6, 12, 18, and 24 months
description: Liver PFS and overall PFS
measure: Overall survival
time frame: 24 months
description: Overall survival
measure: Change in Model for end stage liver disease (MELD)
time frame: 7 and 30 days
description: 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
measure: Change in Child Pugh score
time frame: 7 and 30 days
description: Change in Child Pugh score at 7 and 30 days post TACE
arm group label: Transarterial chemoembolization
arm group type: Experimental
description: Transarterial chemoembolization
intervention type: Combination Product
intervention name: Transarterial chemoembolization
description: 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.
arm group label: Transarterial chemoembolization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperbilirubinemia