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/NCT05994859</url>
    </required_header>
    <id_info>
      <org_study_id>MIIR-15</org_study_id>
      <nct_id>NCT05994859</nct_id>
    </id_info>
    <brief_title>SIRT for Potentially Resectable HCC</brief_title>
    <official_title>Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, 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 Y-90 selective internal&#xD;
        radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma&#xD;
        (HCC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient&#xD;
        with potentially resectable HCC.&#xD;
  &#xD;
        35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this&#xD;
        study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors,&#xD;
        extensive liver involvement or vascular invasion, systematic treatment will be added. If the&#xD;
        patients are evaluated as resectable during follw-up, liver resection will be recommended.&#xD;
  &#xD;
        The primary end point of this study is success rate of conversion to resection. The secondary&#xD;
        endpoints are objective response rate (ORR), disease control rate (DCR), progression-free&#xD;
        survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS)&#xD;
        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">February 9, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 9, 2026</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>Success rate of conversion to resection</measure>
      <time_frame>3 years</time_frame>
      <description>The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>3 years</time_frame>
      <description>The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>3 years</time_frame>
      <description>The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>3 years</time_frame>
      <description>The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to progression (TTP)</measure>
      <time_frame>3 years</time_frame>
      <description>the time interval from first treatment to the first occurrence of disease progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>3 years</time_frame>
      <description>the time from initial objective response (CR or PR) until PD or death, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>3 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>3 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">35</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>SIRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment with SIRT.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>SIRT</intervention_name>
      <description>The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.</description>
      <arm_group_label>SIRT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HCC with diagnosis confirmed pathologically or clinically&#xD;
  &#xD;
            -  No pervious treatment for HCC&#xD;
  &#xD;
            -  At least one measurable intrahepatic target lesion&#xD;
  &#xD;
            -  Potentially resectable HCC: tumor(s) confined to the left/right hemiliver,&#xD;
               with/without invasion to the unilateral branch of the portal vein and/or hepatic vein&#xD;
  &#xD;
            -  Disease amenable to SIRT (after evaluation)&#xD;
  &#xD;
            -  Child-Pugh Class A or without cirrhosis&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1&#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;
            -  Adequate organ and bone marrow function; the blood biochemical examination: platelet&#xD;
               count ≥75×10^9/L, white blood cell count &gt;3.0×10^9/L, absolute value of neutrophils&#xD;
               &gt;1.5×10^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR&lt;1.5 or&#xD;
               PT/APTT normal range&#xD;
  &#xD;
            -  Life expectancy of at least 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tumor involving main portal vein, bilateral branches of portal vein, or vena cava&#xD;
  &#xD;
            -  tumor extention beyond one lobe of the liver&#xD;
  &#xD;
            -  Bilobar tumor distribution&#xD;
  &#xD;
            -  Extrahepatic metastasis&#xD;
  &#xD;
            -  Decompensated liver function, including ascites, bleeding from esophageal and gastric&#xD;
               varices, and/or hepatic encephalopathy&#xD;
  &#xD;
            -  Organ (heart, kidney) dysfunction&#xD;
  &#xD;
            -  HBsAg and anti-HCV antibody positive concurrently&#xD;
  &#xD;
            -  History of malignancy other than HCC&#xD;
  &#xD;
            -  Uncontrolled infection&#xD;
  &#xD;
            -  History of HIV&#xD;
  &#xD;
            -  History of organ and cell transplantation&#xD;
  &#xD;
            -  Patients with bleeding tendency&#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 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 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>unresectable</keyword>
    <keyword>selective internal radiation therapy</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>
    <!-- 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/NCT05994859
  org study id: MIIR-15
  nct id: NCT05994859
  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 Y-90 selective internal
        radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma
        (HCC).
  This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient
        with potentially resectable HCC.
  
        35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this
        study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors,
        extensive liver involvement or vascular invasion, systematic treatment will be added. If the
        patients are evaluated as resectable during follw-up, liver resection will be recommended.
  
        The primary end point of this study is success rate of conversion to resection. The secondary
        endpoints are objective response rate (ORR), disease control rate (DCR), progression-free
        survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS)
        and adverse events (AEs).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Success rate of conversion to resection
  time frame: 3 years
  description: The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
  measure: Objective response rate (ORR)
  time frame: 3 years
  description: The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)
  measure: Disease control rate (DCR)
  time frame: 3 years
  description: The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)
  measure: Progression-free survival (PFS)
  time frame: 3 years
  description: The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first
  measure: Time to progression (TTP)
  time frame: 3 years
  description: the time interval from first treatment to the first occurrence of disease progression
  measure: Duration of response (DOR)
  time frame: 3 years
  description: the time from initial objective response (CR or PR) until PD or death, whichever occurs first
  measure: Overall survival (OS)
  time frame: 3 years
  description: The time from initiation of treatment until the date of death from any cause
  measure: Adverse Events (AEs)
  time frame: 3 years
  description: Number of patients with AEs assessed by NCI CTCAE v5.0.
  arm group label: SIRT
  arm group type: Experimental
  description: Treatment with SIRT.
  intervention type: Procedure
  intervention name: SIRT
  description: The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.
  arm group label: 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