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/NCT06021015</url>
    </required_header>
    <id_info>
      <org_study_id>DEBIRI-TACE</org_study_id>
      <nct_id>NCT06021015</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM</brief_title>
    <official_title>A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for Transcatheter Arterial Chemoembolization of Colorectal Cancer Liver Metastases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongda Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongda Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 a prospective, multicenter, randomized controlled clinical trial to evaluate&#xD;
        the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and&#xD;
        HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with&#xD;
        hepatic metastases through arterial chemoembolization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two&#xD;
        patients with colorectal cancer liver metastases that are not feasible or suitable for&#xD;
        surgical resection will be enrolled in this study. The experimental group received&#xD;
        transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium&#xD;
        acrylate embolization microspheres loaded with 100mg irinotecan and the control group&#xD;
        received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All&#xD;
        patients received 1-2 TACE treatment as needed. The primary end point of this study is&#xD;
        disease control rate (DCR) of target lesions 1 month after the last TACE treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disease control rate (DCR) of target lesions 1 month after the last TACE treatment</measure>
      <time_frame>3 month</time_frame>
      <description>Disease control rate (DCR) of target lesions 1 month after the last TACE treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Success rate</measure>
      <time_frame>3 month</time_frame>
      <description>The success rate of embolization techniques for target lesions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) of target lesions 1 month after first TACE treatment</measure>
      <time_frame>1 month</time_frame>
      <description>Disease control rate (DCR) of target lesions 1 month after first TACE treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>3 month</time_frame>
      <description>Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Equipment performance evaluation</measure>
      <time_frame>3 month</time_frame>
      <description>Equipment performance evaluation: evaluation of conveying performance and degree of embolism</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Colorectal Cancer Liver Metastasis</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Irinotecan and HepaSphere Microspheres</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）</intervention_name>
      <description>Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Irinotecan and HepaSphere Microspheres</intervention_name>
      <description>Irinotecan and HepaSphere Microspheres</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age range from 18 to 80 years old (including threshold), regardless of gender；&#xD;
  &#xD;
            2. Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases,&#xD;
               with complete resection of the primary lesion and no local recurrence;&#xD;
  &#xD;
            3. Researchers believe that liver metastases are not feasible or suitable, or patients&#xD;
               refuse surgical resection；&#xD;
  &#xD;
            4. ECOG score ≤ 2 points, Child Pugh grade A or B；&#xD;
  &#xD;
            5. At least one measurable liver metastasis with a diameter greater than 1 cm without&#xD;
               embolization treatment (the maximum diameter of the target lesion is less than 10 cm)；&#xD;
  &#xD;
            6. Voluntarily participate in this clinical trial and sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with known severe allergy to contrast agents (iodine contrast agents,&#xD;
               gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium&#xD;
               acrylate copolymer) ;&#xD;
  &#xD;
            2. White blood cell count&lt;3.0×109/L, platelet count&lt;75×109/L，hemoglobin&lt;70 g/L；&#xD;
  &#xD;
            3. Total bilirubin&gt;2 times the upper limit of normal value, Alanine transaminase (ALT) or&#xD;
               aspartate aminotransferase (AST) &gt;5 times the upper limit of normal value, Alkaline&#xD;
               phosphatase&gt;2.5 times the upper limit of normal value, albumin&lt;30 g/L;&#xD;
  &#xD;
            4. Creatinine&gt;1.5 times the upper limit of normal value, creatinine clearance rate&lt;30&#xD;
               mL/min;&#xD;
  &#xD;
            5. Prothrombin time and activated partial thromboplastin time&gt;1.5 times the upper limit&#xD;
               of normal value;&#xD;
  &#xD;
            6. Target lesion blood supply artery cannot undergo TACE treatment (the blood supply&#xD;
               artery is too thin，vasospasm or suspected vasospasm，peripheral vascular resistance of&#xD;
               the blood supply artery hinders the entry of embolic microspheres into the lesion&#xD;
               site，severe Atherosclerosis, etc) or there is a risk of embolism (collateral vascular&#xD;
               pathway endangers normal areas, etc)；&#xD;
  &#xD;
            7. The expected survival time is less than 3 months;&#xD;
  &#xD;
            8. Patients who have received embolization therapy for the target lesion or undergo the&#xD;
               first TACE treatment for the target lesion after enrollment and require combined&#xD;
               ablation/radiotherapy;&#xD;
  &#xD;
            9. Pregnant and lactating women, or those who plan to conceive during the study period;&#xD;
  &#xD;
           10. Those who have participated in other intervention clinical trials within one month&#xD;
               before the trial;&#xD;
  &#xD;
           11. The researchers believe that the subjects are intolerant and other unsuitable&#xD;
               candidates for participating in this clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gao-Jun Teng, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhongda Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian Lu, MD</last_name>
      <phone>+8615850654644</phone>
      <email>lujian43307131@126.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
      <investigator_full_name>Gao-jun Teng</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>colorectal cancer</keyword>
    <keyword>liver metastasis</keyword>
    <keyword>embolization microspheres</keyword>
    <keyword>efficacy</keyword>
    <keyword>safety</keyword>
    <keyword>transcatheter arterial chemoembolization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Irinotecan</mesh_term>
    </intervention_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/NCT06021015
  org study id: DEBIRI-TACE
  nct id: NCT06021015
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective, multicenter, randomized controlled clinical trial to evaluate
        the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and
        HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with
        hepatic metastases through arterial chemoembolization.
  This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two
        patients with colorectal cancer liver metastases that are not feasible or suitable for
        surgical resection will be enrolled in this study. The experimental group received
        transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium
        acrylate embolization microspheres loaded with 100mg irinotecan and the control group
        received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All
        patients received 1-2 TACE treatment as needed. The primary end point of this study is
        disease control rate (DCR) of target lesions 1 month after the last TACE treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
  time frame: 3 month
  description: Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
  measure: Success rate
  time frame: 3 month
  description: The success rate of embolization techniques for target lesions
  measure: Disease control rate (DCR) of target lesions 1 month after first TACE treatment
  time frame: 1 month
  description: Disease control rate (DCR) of target lesions 1 month after first TACE treatment
  measure: Objective response rate (ORR)
  time frame: 3 month
  description: Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment
  measure: Equipment performance evaluation
  time frame: 3 month
  description: Equipment performance evaluation: evaluation of conveying performance and degree of embolism
  arm group label: Experimental group
  arm group type: Experimental
  description: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
  arm group label: Control group
  arm group type: Active Comparator
  description: Irinotecan and HepaSphere Microspheres
  intervention type: Device
  intervention name: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
  description: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
  arm group label: Experimental group
  intervention type: Device
  intervention name: Irinotecan and HepaSphere Microspheres
  description: Irinotecan and HepaSphere Microspheres
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Gao-Jun Teng, MD
  role: Principal Investigator
  affiliation: Zhongda Hospital
  last name: Jian Lu, MD
  phone: +8615850654644
  email: lujian43307131@126.com
  responsible party type: Principal Investigator
  investigator affiliation: Zhongda Hospital
  investigator full name: Gao-jun Teng
  investigator title: Professor
  mesh term: Colorectal Neoplasms
  mesh term: Neoplasm Metastasis
  mesh term: Liver Neoplasms
  mesh term: Irinotecan
  sharing ipd: No