<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/NCT03024684</url>
  </required_header>
  <id_info>
    <org_study_id>105005</org_study_id>
    <nct_id>NCT03024684</nct_id>
  </id_info>
  <brief_title>Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment</brief_title>
  <acronym>SHOT</acronym>
  <official_title>Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiayi Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>E-DA Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tainan Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chi Mei Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chiayi Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether statin could prevent recurrence of&#xD;
      hepatocellular carcinoma after curative treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center double-blind randomized placebo-controlled trial. A total of 240&#xD;
      patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After&#xD;
      complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to&#xD;
      receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control&#xD;
      group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by&#xD;
      dynamic computed tomography (or magnetic resonance image) every 4 months. They will be&#xD;
      followed up until death, withdrawal from participation, study termination, or 3 years after&#xD;
      the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of&#xD;
      recurrent HCC between the intervention group and control counterpart. Secondary endpoints are&#xD;
      occurrence of clinical complications related to hepatic decompensation (including&#xD;
      gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy,&#xD;
      hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause&#xD;
      mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart</measure>
    <time_frame>3 years</time_frame>
    <description>Recurrence rate of HCC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurrence of clinical complications related to hepatic decompensation</measure>
    <time_frame>3 years</time_frame>
    <description>clinical complications or hepatic decompensation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>HepatoCellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Statin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin 10mg oral once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo (sugar pill) once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin 10mg daily</description>
    <arm_group_label>Statin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo one tablet daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with HCC BCLC stage 0 or A who received curative radiofrequency ablation&#xD;
             or hepatic resection could be eligible.&#xD;
&#xD;
          -  Individuals who had single HCC (size &gt; 5.0 cm) received hepatic resection would be&#xD;
             eligible&#xD;
&#xD;
          -  Individuals with prior history of HCC who had ever received curative ablation or&#xD;
             hepatic resection without any recurrence for more than 2 years could be eligible if&#xD;
             they had a new episode of recurrent HCC which could meet either of the former two&#xD;
             criteria.&#xD;
&#xD;
          -  After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of&#xD;
             local residual or recurrent tumors according to the dynamic CT or MRI could be&#xD;
             enrolled&#xD;
&#xD;
          -  The diagnosis of fresh HCC should be compatible with either pathological report or&#xD;
             meet the criteria of AASLD guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undetermined nature of hepatic tumor&#xD;
&#xD;
          -  HCC with extrahepatic metastasis or major vascular invasion&#xD;
&#xD;
          -  With other malignant disease&#xD;
&#xD;
          -  Child Pugh score &gt;7&#xD;
&#xD;
          -  Previous history of CAD event (angina, unstable angina, acute myocardial infarction)&#xD;
             or ischemic stroke&#xD;
&#xD;
          -  Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)&#xD;
&#xD;
          -  Advanced CKD (eGFR&lt;30) or ESRD&#xD;
&#xD;
          -  Severe comorbidity with life expectancy &lt; 2 years&#xD;
&#xD;
          -  Allergy to statin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Po Yueh Chen, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ditmanson Medical Foundation Chia-Yi Christian Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Po Yueh Chen, Doctor</last_name>
    <phone>+886919860356</phone>
    <email>hdilwy7@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ditmanson Medical Foundation Chiayi Christian Hospital</name>
      <address>
        <city>Chiayi City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>E-DA Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tainan Municipal Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital Yun-Lin Branch</name>
      <address>
        <city>Yunlin</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>statin</keyword>
  <keyword>curative ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</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/NCT03024684
org study id: 105005
nct id: NCT03024684
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate whether statin could prevent recurrence of
      hepatocellular carcinoma after curative treatment
This is a multi-center double-blind randomized placebo-controlled trial. A total of 240
      patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After
      complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to
      receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control
      group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by
      dynamic computed tomography (or magnetic resonance image) every 4 months. They will be
      followed up until death, withdrawal from participation, study termination, or 3 years after
      the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of
      recurrent HCC between the intervention group and control counterpart. Secondary endpoints are
      occurrence of clinical complications related to hepatic decompensation (including
      gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy,
      hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause
      mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
time frame: 3 years
description: Recurrence rate of HCC
measure: occurrence of clinical complications related to hepatic decompensation
time frame: 3 years
description: clinical complications or hepatic decompensation
arm group label: Statin
arm group type: Experimental
description: Atorvastatin 10mg oral once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Matched placebo (sugar pill) once daily
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin 10mg daily
arm group label: Statin
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo one tablet daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Po Yueh Chen, Doctor
role: Principal Investigator
affiliation: Ditmanson Medical Foundation Chia-Yi Christian Hospital
last name: Po Yueh Chen, Doctor
phone: +886919860356
email: hdilwy7@gmail.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Recurrence
mesh term: Atorvastatin
sharing ipd: No