xml: <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/NCT06001567</url>
    </required_header>
    <id_info>
      <org_study_id>MIIR-12</org_study_id>
      <nct_id>NCT06001567</nct_id>
    </id_info>
    <brief_title>Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC</brief_title>
    <official_title>A Single-center, Single-arm Study of Avatrombopag for Patients With Hepatocellular Carcinoma and Thrombocytopenia Who Intend to Undergo Transarterial Chemoembolization and/or Hepatic Arterial Infusion Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital of Guangzhou Medical University</source>
    <oversight_info>
      <has_dmc>No</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>
        This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in&#xD;
        patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial&#xD;
        chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective study to evaluate the efficacy of avatrombopag for&#xD;
        thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.&#xD;
  &#xD;
        30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet&#xD;
        count [PLT] &lt;40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered&#xD;
        to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be&#xD;
        discontinued.&#xD;
  &#xD;
        The primary end point of this study is the proportion of patients with PLT &gt;75×10^9/L or&#xD;
        doubling from baseline. The secondary endpoints are the proportion of patients with PLT&#xD;
        &gt;75×10^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT,&#xD;
        the proportion of patients who successfully receive TACE/HAIC, .adverse events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 13, 2024</primary_completion_date>
    <phase>Phase 2</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>Proportion of patients with PLT &gt;75×10^9/L or doubling from baseline</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of patients with PLT &gt;75×10^9/L or doubling from baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with PLT &gt;75×10^9/L</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of patients with PLT &gt;75×10^9/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with PLT doubling from baseline</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of patients with PLT doubling from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Increace in PLT</measure>
      <time_frame>1 year</time_frame>
      <description>the Increace in PLT after treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who successfully receive TACE/HAIC</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of patients who successfully receive TACE/HAIC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events (AEs)</measure>
      <time_frame>1 year</time_frame>
      <description>Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Thrombocytopenia</condition>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Avatrombopag</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive avatrombopag treatment 5-10 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Avatrombopag</intervention_name>
      <description>Avatrombopag (platelet count [PLT] &lt;40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be discontinued.</description>
      <arm_group_label>Avatrombopag</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HCC with diagnosis confirmed pathologically or clinically&#xD;
  &#xD;
            -  Patients who need to receive TACE and/or HAIC, or have plans to undergo another&#xD;
               treatment (3-6 weeks after the previous treatment)&#xD;
  &#xD;
            -  Child Pugh class A or B&#xD;
  &#xD;
            -  ECOG PS 0-2&#xD;
  &#xD;
            -  PLT ≤ 75×10^9/L (10 days before interventional therapy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Thrombocytopenia caused by hematological diseases, non chemotherapy related&#xD;
               thrombocytopenia (excluding liver cirrhosis with hypersplenism)&#xD;
  &#xD;
            -  PLT &lt;30×10^9/L&#xD;
  &#xD;
            -  History of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome&#xD;
  &#xD;
            -  History of arterial or venous thrombosis within 6 months&#xD;
  &#xD;
            -  Uncontrolled severe infections&#xD;
  &#xD;
            -  Pregnant or breastfeeding female patients&#xD;
  &#xD;
            -  Immune deficiencies, such as autoimmune diseases, HIV infected individuals, etc&#xD;
  &#xD;
            -  Anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment&#xD;
               period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory&#xD;
               drugs, aspirin, verapamil, Ticlopidine, clopidogrel, glycoprotein IIb/IIIa&#xD;
               antagonists, erythropoietin, etc;&#xD;
  &#xD;
            -  Administration of blood products within 7 days prior to the baseline visit (excluding&#xD;
               albumin infusion)&#xD;
  &#xD;
            -  Allergy to avatrombopag or any of its formulations&#xD;
  &#xD;
            -  History (such as gastrointestinal bleeding within 3 months, high risk of thrombosis,&#xD;
               such as portal vein main flow velocity&lt;10cm/s) which may affect the safety of the&#xD;
               patients or their ability to complete the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mingyue Cai, Dr.</last_name>
      <phone>+86-20-34156205</phone>
      <email>cai020@yeah.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kangshun Zhu, Dr.</last_name>
      <phone>+86-20-34156205</phone>
      <email>zhksh010@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510260</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kangshun Zhu, Dr.</last_name>
        <phone>+86-20-34156205</phone>
        <email>zhksh010@126.com</email>
      </contact>
      <investigator>
        <last_name>Kangshun Zhu, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mingyue Cai, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Thrombocytopenia</keyword>
    <keyword>Hepatocellular Carcinoma</keyword>
    <keyword>Transarterial Chemoembolization</keyword>
    <keyword>hepatic arterial infusion chemotherapy</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>Thrombocytopenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001567
  org study id: MIIR-12
  nct id: NCT06001567
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in
        patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial
        chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).
  This is a single-center, prospective study to evaluate the efficacy of avatrombopag for
        thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.
  
        30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet
        count [PLT] <40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered
        to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be
        discontinued.
  
        The primary end point of this study is the proportion of patients with PLT >75×10^9/L or
        doubling from baseline. The secondary endpoints are the proportion of patients with PLT
        >75×10^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT,
        the proportion of patients who successfully receive TACE/HAIC, .adverse events.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of patients with PLT >75×10^9/L or doubling from baseline
  time frame: 1 year
  description: The proportion of patients with PLT >75×10^9/L or doubling from baseline
  measure: Proportion of patients with PLT >75×10^9/L
  time frame: 1 year
  description: The proportion of patients with PLT >75×10^9/L
  measure: Proportion of patients with PLT doubling from baseline
  time frame: 1 year
  description: The proportion of patients with PLT doubling from baseline
  measure: Increace in PLT
  time frame: 1 year
  description: the Increace in PLT after treatment
  measure: Proportion of patients who successfully receive TACE/HAIC
  time frame: 1 year
  description: The proportion of patients who successfully receive TACE/HAIC
  measure: Adverse events (AEs)
  time frame: 1 year
  description: Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
  arm group label: Avatrombopag
  arm group type: Experimental
  description: Patients receive avatrombopag treatment 5-10 days.
  intervention type: Drug
  intervention name: Avatrombopag
  description: Avatrombopag (platelet count [PLT] <40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be discontinued.
  arm group label: Avatrombopag
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mingyue Cai, Dr.
  phone: +86-20-34156205
  email: cai020@yeah.net
  last name: Kangshun Zhu, Dr.
  phone: +86-20-34156205
  email: zhksh010@163.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Thrombocytopenia
  sharing ipd: No