<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/NCT03299036</url>
  </required_header>
  <id_info>
    <org_study_id>B-BR-105-054</org_study_id>
    <nct_id>NCT03299036</nct_id>
  </id_info>
  <brief_title>Drug-loadable（T-ACE Beads）for Hepatoma Embolization Therapy</brief_title>
  <official_title>Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Industrial Technology Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere&#xD;
      (T-ACE Beads with doxorubicin) interventional therapy for patients with liver cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the safety and tolerability of Taiwan ACE Beads with doxorubicin used&#xD;
      for chemoembolization for the treatment of unresectable hepatocellular carcinoma.&#xD;
&#xD;
      The investigators will study the overall response rates of lesions with Taiwan ACE Beads.&#xD;
&#xD;
      The procedure is similar with the other commercializing drug-eluting beads. At the target&#xD;
      vessels, radiologists will inject doxorubicin with Taiwan ACE Beads instead of Gelfoam or PVA&#xD;
      (polyvinyl alcohol). The end point of injection is also similar with conventional TACE.&#xD;
&#xD;
      Determine the complication rates, progression free survival (PFS) and overall survival (OS)&#xD;
      following Taiwan ACE Beads embolization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">October 16, 2018</completion_date>
  <primary_completion_date type="Actual">October 16, 2018</primary_completion_date>
  <phase>N/A</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>Patients Survival (Safety)</measure>
    <time_frame>An average of 12 weeks.</time_frame>
    <description>Survival rate will be evaluated since treatment day until the date of death or final observation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria</measure>
    <time_frame>Three months</time_frame>
    <description>mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Level of AFP</measure>
    <time_frame>An average of 12 weeks</time_frame>
    <description>Collect Doxorubicin's blood concentration, 5 mL each time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cancer of Liver</condition>
  <arm_group>
    <arm_group_label>Taiwan ACE Beads with doxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Taiwan ACE Beads with doxorubicin</intervention_name>
    <description>Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.</description>
    <arm_group_label>Taiwan ACE Beads with doxorubicin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet all of the following inclusion criteria in order to be entered into the&#xD;
        study:&#xD;
&#xD;
        A. Both genders of patients age 20 or older.&#xD;
&#xD;
        B. Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)&#xD;
&#xD;
          1. Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.&#xD;
&#xD;
          2. High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer&#xD;
             image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or&#xD;
             Angiography).&#xD;
&#xD;
          3. High risk patients (Viral hepatitis B or C cirrhotics) with evidence of enlarging&#xD;
             image of liver cancer via more than two follow-up records.&#xD;
&#xD;
        C. In intermediate stage by BCLC staging, tumor size under 8 centimeters, with liver&#xD;
        function at Child-Pugh class ≤ 8, and is either difficult to accept an operation or&#xD;
        reluctant to accept any operation.&#xD;
&#xD;
        D. Disease can be treated by transarterial chemoembolization, and can be evaluated by&#xD;
        Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT).&#xD;
&#xD;
        E. Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        If patients meet any of the following criteria they may not be entered into the study:&#xD;
&#xD;
        A. major branch of portal vein has been invaded already; extrahepatic metastasis or the the&#xD;
        other malignant tumors.&#xD;
&#xD;
        B. Evidences of decompensation: Total Bilirubin&gt;2, PT prolong&gt;3 seconds, Child-Pugh&#xD;
        class&gt;8, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.&#xD;
&#xD;
        C. Tumor size (diameter) larger than 8 centimeters.&#xD;
&#xD;
        D. Not on dialysis with Creatinine &gt;2.0 mg/dL.&#xD;
&#xD;
        E. Allergic to iodine or other injections.&#xD;
&#xD;
        F. Other main organ failure (Heart, Lung, or Kidney).&#xD;
&#xD;
        G. WBC&lt;3000, or Platelet Count &lt;50,000 mg/dL.&#xD;
&#xD;
        H. Performance status ECOG of 3 or more.&#xD;
&#xD;
        I. Pregnant women and breath feeding women.&#xD;
&#xD;
        J. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.&#xD;
&#xD;
        K. Prominent AV shunt.&#xD;
&#xD;
        L. Severe atherosclerosis.&#xD;
&#xD;
        M. Vasospasm or possible major vascular injury.&#xD;
&#xD;
        N. Arteriovenous shunt patients, diameter larger than the size of microsphere available.&#xD;
&#xD;
        O. Collateral vascular exists and may endanger non-targeted area during arterial&#xD;
        chemoembolization.&#xD;
&#xD;
        P. Contraindications for doxorubicin.&#xD;
&#xD;
        Q. Numerous of tumors locate at different lobes, high risk of Hepatic insufficiency.&#xD;
&#xD;
        R. Unwilling to sign a written informed consent form.&#xD;
&#xD;
        S. Allergic to pharmaceutical excipients related to Microspheres.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xi-Zhang Lin</last_name>
    <role>Study Director</role>
    <affiliation>Department of Internal Medicine, National Cheng Kung University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.</citation>
    <PMID>26339465</PMID>
  </reference>
  <reference>
    <citation>Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, Chuang MT. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015 Jan-Feb;16(1):125-32. doi: 10.3348/kjr.2015.16.1.125. Epub 2015 Jan 9.</citation>
    <PMID>25598680</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatoma</keyword>
  <keyword>Transcatheter Arterial chemo-embolization</keyword>
  <keyword>Microsphere</keyword>
  <keyword>Doxorubicin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03299036
org study id: B-BR-105-054
nct id: NCT03299036
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere
      (T-ACE Beads with doxorubicin) interventional therapy for patients with liver cancer
The study will evaluate the safety and tolerability of Taiwan ACE Beads with doxorubicin used
      for chemoembolization for the treatment of unresectable hepatocellular carcinoma.

      The investigators will study the overall response rates of lesions with Taiwan ACE Beads.

      The procedure is similar with the other commercializing drug-eluting beads. At the target
      vessels, radiologists will inject doxorubicin with Taiwan ACE Beads instead of Gelfoam or PVA
      (polyvinyl alcohol). The end point of injection is also similar with conventional TACE.

      Determine the complication rates, progression free survival (PFS) and overall survival (OS)
      following Taiwan ACE Beads embolization.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients Survival (Safety)
time frame: An average of 12 weeks.
description: Survival rate will be evaluated since treatment day until the date of death or final observation.
measure: Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
time frame: Three months
description: mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
measure: Serum Level of AFP
time frame: An average of 12 weeks
description: Collect Doxorubicin's blood concentration, 5 mL each time
arm group label: Taiwan ACE Beads with doxorubicin
arm group type: Experimental
description: The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.
intervention type: Device
intervention name: Taiwan ACE Beads with doxorubicin
description: Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.
arm group label: Taiwan ACE Beads with doxorubicin
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Xi-Zhang Lin
role: Study Director
affiliation: Department of Internal Medicine, National Cheng Kung University Hospital
facility: 
country: Taiwan
citation: Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
PMID: 26339465
citation: Liu YS, Ou MC, Tsai YS, Lin XZ, Wang CK, Tsai HM, Chuang MT. Transarterial chemoembolization using gelatin sponges or microspheres plus lipiodol-doxorubicin versus doxorubicin-loaded beads for the treatment of hepatocellular carcinoma. Korean J Radiol. 2015 Jan-Feb;16(1):125-32. doi: 10.3348/kjr.2015.16.1.125. Epub 2015 Jan 9.
PMID: 25598680
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
mesh term: Doxorubicin
sharing ipd: No