<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/NCT03273608</url>
  </required_header>
  <id_info>
    <org_study_id>HEPA-Taiwan-001</org_study_id>
    <nct_id>NCT03273608</nct_id>
  </id_info>
  <brief_title>Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients</brief_title>
  <official_title>Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients: Safety &amp; Efficacy Registry in Taiwan (SUPER- Taiwan)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this multicenter registry is to gather the safety, efficacy and survival data&#xD;
      in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order&#xD;
      to provide clinical evidence in HCC management to physicians in the region, and to support&#xD;
      the application of deTACE in treating advanced HCC patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this multicenter registry is to gather the safety, efficacy and survival data&#xD;
      in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order&#xD;
      to provide clinical evidence on deTACE in HCC management to physicians in the region, and to&#xD;
      support the application of in treating advanced HCC patients.&#xD;
&#xD;
        1. Primary Objective:&#xD;
&#xD;
           To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in&#xD;
           intermediate and advanced HCC patients in Taiwan.&#xD;
&#xD;
        2. Secondary Objectives:&#xD;
&#xD;
             1. To evaluate the overall tumor response of chemoembolization with drug-eluting&#xD;
                microsphere in intermediate and advanced HCC patients. The tumor response is&#xD;
                according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)&#xD;
                criteria.&#xD;
&#xD;
             2. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting&#xD;
                microsphere) by chemoembolization with drug-eluting microsphere in intermediate and&#xD;
                advanced HCC patients.&#xD;
&#xD;
             3. To evaluate the safety profile of chemoembolization with drug-eluting microsphere&#xD;
                in intermediate and advanced HCC patients.&#xD;
&#xD;
        3. Exploratory Objectives:&#xD;
&#xD;
             1. To evaluate the downstaging and downsizing potential of chemoembolization with&#xD;
                drug-eluting microsphere in intermediate and advanced HCC patients to within Milan&#xD;
                Criteria and to within Resection margin.&#xD;
&#xD;
             2. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of&#xD;
                chemoembolization with drug-eluting microsphere in intermediate and advanced HCC&#xD;
                patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 14, 2016</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Response</measure>
    <time_frame>1 year</time_frame>
    <description>Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event (AE)</measure>
    <time_frame>1 year</time_frame>
    <description>Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Objectives, Time-To-Progression (TTP)</measure>
    <time_frame>1 year</time_frame>
    <description>To define all participants from the day of the first HepaSphere Treatment until tumor progression or death is first reported, whichever comes first.</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Objectives, Downstaging</measure>
    <time_frame>1 year</time_frame>
    <description>Tumor staging will be accessed according to BCLC staging system and Milan criteria, and will be reviewed at follow-up until end of study or death.</description>
  </other_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC&#xD;
        Patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Patients must meet all of the following inclusion criteria in order to&#xD;
        be entered into the study:&#xD;
&#xD;
          -  Age 20 or older.&#xD;
&#xD;
          -  Patient has signed informed consent.&#xD;
&#xD;
          -  Patient must have a diagnosis of hepatocellular cancer confirmed by AASLD and at least&#xD;
             one of the following method:&#xD;
&#xD;
               -  Magnetic resonance imaging (MRI) with early enhancement and delayed enhancement&#xD;
                  washout of at least one solid liver lesion &gt; 1 cm.&#xD;
&#xD;
               -  Contrast enhanced computed tomography (CT) with early enhancement and delayed&#xD;
                  enhancement washout of at least one solid liver lesion &gt; 1 cm.&#xD;
&#xD;
               -  Histological confirmation is required for lesions with inconclusive features.&#xD;
&#xD;
          -  Patient must not be suitable for treatment by resection or percutaneous ablation at&#xD;
             time of study entry.&#xD;
&#xD;
               -  Patients not suitable for ablation due to lesion location may be enrolled.&#xD;
&#xD;
               -  Patients with HCC recurrence but not suitable for resection or ablation maybe&#xD;
                  enrolled.&#xD;
&#xD;
          -  Patient MUST be with either BCLC stage B OR C, and meet the following criteria:&#xD;
&#xD;
               -  Stage Child-Pugh A or B AND&#xD;
&#xD;
               -  Performance status ECOG ≤ 1 WITH Vascular Invasion or WITHOUT Vascular invasion.&#xD;
&#xD;
          -  Patient has a life expectancy of at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:If patients meet any of the following criteria they may not be entered&#xD;
        into the study:&#xD;
&#xD;
          -  Current or previous treatment with chemo- or radiation therapy or sorafenib or&#xD;
             drug-eluting chemoembolization (deTACE).&#xD;
&#xD;
          -  Patients with concurrent cancer except non-melanomatous skin cancer.&#xD;
&#xD;
          -  Female patients who are pregnant, breastfeeding, or premenopausal and not using an&#xD;
             effective method of contraceptive.&#xD;
&#xD;
          -  Performance status ECOG &gt; 1.&#xD;
&#xD;
          -  Child-Pugh Class C.&#xD;
&#xD;
          -  Occlusive tumor thrombus to the main portal trunk.&#xD;
&#xD;
          -  Active gastrointestinal bleeding.&#xD;
&#xD;
          -  Evidence of uncorrectable bleeding diathesis.&#xD;
&#xD;
          -  Extra-Hepatic spread of the HCC.&#xD;
&#xD;
          -  Encephalopathy not adequately controlled medically.&#xD;
&#xD;
          -  Presence of ascites not controlled medically.&#xD;
&#xD;
          -  Any contraindication for MRI/ CT (eg. metallic implants).&#xD;
&#xD;
          -  Allergy to contrast media that cannot be managed with prophylaxis.&#xD;
&#xD;
          -  Any contraindication to arteriography.&#xD;
&#xD;
          -  Any contraindication for doxorubicin administration.&#xD;
&#xD;
          -  Any contraindication for hepatic embolization. Porto-systemic shunt, or an&#xD;
             arteriovenous shunt that cannot be adequately closed prior to chemoembolization.&#xD;
             Hepatofugal blood flow. Serum creatinine &gt; 2mg/dL. Other condition deemed exclusionary&#xD;
             by physician. Uncorrectable impaired clotting.&#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>Yi-Hsiang Huang, M.D. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-Hsiang Huang, M.D. Ph.D.</last_name>
    <phone>+886-2-28757506</phone>
    <email>yhhhuang@vghtpe.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi-Hsiang Huang, M.D. Ph.D.</last_name>
      <phone>+886-2-28757506</phone>
      <email>yhhuang@vghtpe.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Professor Yi-Hsiang Huang</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Advanced HCC</keyword>
  <keyword>Unresectable</keyword>
  <keyword>deTACE</keyword>
  <keyword>HepaSphere</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</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/NCT03273608
org study id: HEPA-Taiwan-001
nct id: NCT03273608
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this multicenter registry is to gather the safety, efficacy and survival data
      in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order
      to provide clinical evidence in HCC management to physicians in the region, and to support
      the application of deTACE in treating advanced HCC patients.
The purpose of this multicenter registry is to gather the safety, efficacy and survival data
      in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order
      to provide clinical evidence on deTACE in HCC management to physicians in the region, and to
      support the application of in treating advanced HCC patients.

        1. Primary Objective:

           To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in
           intermediate and advanced HCC patients in Taiwan.

        2. Secondary Objectives:

             1. To evaluate the overall tumor response of chemoembolization with drug-eluting
                microsphere in intermediate and advanced HCC patients. The tumor response is
                according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
                criteria.

             2. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting
                microsphere) by chemoembolization with drug-eluting microsphere in intermediate and
                advanced HCC patients.

             3. To evaluate the safety profile of chemoembolization with drug-eluting microsphere
                in intermediate and advanced HCC patients.

        3. Exploratory Objectives:

             1. To evaluate the downstaging and downsizing potential of chemoembolization with
                drug-eluting microsphere in intermediate and advanced HCC patients to within Milan
                Criteria and to within Resection margin.

             2. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of
                chemoembolization with drug-eluting microsphere in intermediate and advanced HCC
                patients.
observational model: Case-Only
time perspective: Prospective
measure: Overall survival
time frame: 1 year
description: To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.
measure: Tumor Response
time frame: 1 year
description: Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.
measure: Adverse Event (AE)
time frame: 1 year
description: Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.
measure: Exploratory Objectives, Time-To-Progression (TTP)
time frame: 1 year
description: To define all participants from the day of the first HepaSphere Treatment until tumor progression or death is first reported, whichever comes first.
measure: Exploratory Objectives, Downstaging
time frame: 1 year
description: Tumor staging will be accessed according to BCLC staging system and Milan criteria, and will be reviewed at follow-up until end of study or death.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yi-Hsiang Huang, M.D. Ph.D.
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Yi-Hsiang Huang, M.D. Ph.D.
phone: +886-2-28757506
email: yhhhuang@vghtpe.gov.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Professor Yi-Hsiang Huang
mesh term: Carcinoma, Hepatocellular