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/NCT05992584</url>
    </required_header>
    <id_info>
      <org_study_id>MIIR-14</org_study_id>
      <nct_id>NCT05992584</nct_id>
    </id_info>
    <brief_title>Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC</brief_title>
    <official_title>Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial</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 and safety of lenvatinib, sintilimab plus&#xD;
        Y-90 selective internal radiation therapy (SIRT) for patients with unresectable&#xD;
        intermediate-advanced hepatocellular carcinoma (HCC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib,&#xD;
        sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.&#xD;
  &#xD;
        30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in&#xD;
        this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight &lt;60kg,&#xD;
        8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up&#xD;
        to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed&#xD;
        consent, loss of follow-up, death, or other circumstances that require termination of&#xD;
        treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable&#xD;
        toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances&#xD;
        that require termination of treatment, whichever occurs first.&#xD;
  &#xD;
        The primary end point of this study is Progression free survival (PFS) per mRECIST. The&#xD;
        secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control&#xD;
        rate (DCR), overall survival (OS) and adverse events (AEs).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">August 9, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 9, 2026</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>Progression free survival (PFS) according to mRECIST</measure>
      <time_frame>2.5 years</time_frame>
      <description>The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS) according to RECIST 1.1</measure>
      <time_frame>2.5 years</time_frame>
      <description>The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>2.5 years</time_frame>
      <description>The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>2.5 years</time_frame>
      <description>The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>2.5 years</time_frame>
      <description>The time from initiation of treatment until the date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events (AEs)</measure>
      <time_frame>2.5 years</time_frame>
      <description>Number of patients with AEs assessed by NCI CTCAE v5.0.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Len-Sin-SIRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lenvatinib, sintilimab plus SIRT</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lenvatinib, sintilimab plus SIRT</intervention_name>
      <description>Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight &lt;60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.</description>
      <arm_group_label>Len-Sin-SIRT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or&#xD;
               clinically&#xD;
  &#xD;
            -  At least one measurable untreated lesion&#xD;
  &#xD;
            -  Intrahepatic tumors can be treated with 1-2 session of SIRT&#xD;
  &#xD;
            -  Child-Pugh score 5-7&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1&#xD;
  &#xD;
            -  Life expectancy of at least 3 months&#xD;
  &#xD;
            -  Patients with active hepatitis B are allowed, but they need to receive antiviral&#xD;
               treatment to achieve a HBV DNA&lt;10^3 IU/mL&#xD;
  &#xD;
            -  Patients with hepatitis C need to finish the anti-HCV treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  tumor extent ≥70% liver occupation&#xD;
  &#xD;
            -  Tumor thrombus involving main portal vein or both the first left and right branch of&#xD;
               portal vein&#xD;
  &#xD;
            -  Vena cava invasion&#xD;
  &#xD;
            -  Central nervous system metastasis&#xD;
  &#xD;
            -  Metastatic disease that involves major airways or blood vessels&#xD;
  &#xD;
            -  Patients who previously received hepatic arterial infusion chemotherapy (HAIC),&#xD;
               transarterial chemoembolization (TACE), transarterial embolization (TAE),&#xD;
               radiotherapy, systemic therapy, or immunotherapy for HCC&#xD;
  &#xD;
            -  History of organ and cell transplantation&#xD;
  &#xD;
            -  Prior esophageal and/or gastric varices bleeding&#xD;
  &#xD;
            -  History of hepatic encephalopathy&#xD;
  &#xD;
            -  Peripheral blood white blood cell count&lt;3×10^9/L, platelet count&lt;50×10^9/L&#xD;
  &#xD;
            -  Prolongation of prothrombin time ≥ 4 seconds&#xD;
  &#xD;
            -  Severe organ dysfunction (heart, lungs, kidneys)&#xD;
  &#xD;
            -  History of malignancy other than HCC&#xD;
  &#xD;
            -  HBsAg and anti-HCV antibody positive concurrently&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV) infected&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</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 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 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>Hepatocellular Carcinoma</keyword>
    <keyword>Lenvatinib</keyword>
    <keyword>Sintilimab</keyword>
    <keyword>Yttrium-90</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lenvatinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05992584
  org study id: MIIR-14
  nct id: NCT05992584
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus
        Y-90 selective internal radiation therapy (SIRT) for patients with unresectable
        intermediate-advanced hepatocellular carcinoma (HCC).
  This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib,
        sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.
  
        30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in
        this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg,
        8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up
        to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed
        consent, loss of follow-up, death, or other circumstances that require termination of
        treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable
        toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances
        that require termination of treatment, whichever occurs first.
  
        The primary end point of this study is Progression free survival (PFS) per mRECIST. The
        secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control
        rate (DCR), overall survival (OS) and adverse events (AEs).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression free survival (PFS) according to mRECIST
  time frame: 2.5 years
  description: The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
  measure: Progression free survival (PFS) according to RECIST 1.1
  time frame: 2.5 years
  description: The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
  measure: Objective response rate (ORR)
  time frame: 2.5 years
  description: The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1
  measure: Disease control rate (DCR)
  time frame: 2.5 years
  description: The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
  measure: Overall survival (OS)
  time frame: 2.5 years
  description: The time from initiation of treatment until the date of death from any cause.
  measure: Adverse Events (AEs)
  time frame: 2.5 years
  description: Number of patients with AEs assessed by NCI CTCAE v5.0.
  arm group label: Len-Sin-SIRT
  arm group type: Experimental
  description: Lenvatinib, sintilimab plus SIRT
  intervention type: Drug
  intervention name: Lenvatinib, sintilimab plus SIRT
  description: Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
  arm group label: Len-Sin-SIRT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  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: Lenvatinib
  sharing ipd: Undecided