<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/NCT04417933</url>
  </required_header>
  <id_info>
    <org_study_id>202001012</org_study_id>
    <nct_id>NCT04417933</nct_id>
  </id_info>
  <brief_title>Tumor Electric Fields Treatment System for Glioblastoma</brief_title>
  <official_title>A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunan An Tai Kang Cheng Biotechnology Co., Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xiangya Hospital of Central South 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This early phase I trial will investigate the safety and feasibility of applying the Tumor&#xD;
      Electric Fields Treatment System to subjects with recurrent glioblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy&#xD;
      with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields&#xD;
      Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric&#xD;
      Fields Treatment System to subjects with recurrent GBM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 7, 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <phase>Early Phase 1</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The treatment-related adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients who experienced a treatment-related adverse event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Progression</measure>
    <time_frame>12 months</time_frame>
    <description>Time to progression of patients with recurrent glioblastoma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients alive at 12 months.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Tumor Electric Fields Treatment System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tumor Electric Fields Treatment System</intervention_name>
    <description>Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.</description>
    <arm_group_label>Tumor Electric Fields Treatment System</arm_group_label>
    <other_name>ASCLU-300</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV,&#xD;
             supratentorial location);&#xD;
&#xD;
          -  Age between 18 and 65 years, male or female;&#xD;
&#xD;
          -  Previously completed radiotherapy and at least two cycles of chemotherapy;&#xD;
&#xD;
          -  With imaging or pathological evidence of tumor recurrence;&#xD;
&#xD;
          -  Karnofsky performance score (KPS) score ≥ 70 before intervention;&#xD;
&#xD;
          -  With a life expectancy more than 3 months;&#xD;
&#xD;
          -  Adopted effective contraceptive measures at child-bearing age;&#xD;
&#xD;
          -  Provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unwilling to use the equipment ≥ 18h per day;&#xD;
&#xD;
          -  With poor compliance or live too far from the research center, who cannot keep regular&#xD;
             follow-up or adjust the electrode position of the treatment equipment, and who refuse&#xD;
             to receive follow-up to terminal survival;&#xD;
&#xD;
          -  With poor healing of scalp wound, poor scalp condition, large skull defect or other&#xD;
             cases where electrodes are not suitable for wearing;&#xD;
&#xD;
          -  Within 3 months from radiotherapy;&#xD;
&#xD;
          -  Within 4 weeks from the last cycle of chemotherapy;&#xD;
&#xD;
          -  Within 4 weeks from surgery for recurrence;&#xD;
&#xD;
          -  Participated in other clinical trials.&#xD;
&#xD;
          -  Pregnant;&#xD;
&#xD;
          -  Epilepsy symptoms not effectively controlled;&#xD;
&#xD;
          -  Blood and biochemical indicators in the following range: A. Liver function impairment:&#xD;
             AST or ALT &gt; 3 times the upper limit of normal; B. Total bilirubin&gt; upper limit of&#xD;
             normal value; C. Renal impairment: serum creatinine&gt;1.7mg /dL (&gt;150 mol/L); D.&#xD;
             Coagulopathy: PT or APTT &gt;1.5 times normal; E. Platelets counts &lt; 100x10^9/L; F.&#xD;
             Absolute neutrophils count &lt; 1x10^9/L; G. Hemoglobin &lt; 100g/L;&#xD;
&#xD;
          -  With severe infectious diseases, such as acute severe infection and HIV positive;&#xD;
&#xD;
          -  Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator,&#xD;
             severe intracranial edema, increased intracranial pressure resulting in midline&#xD;
             shift&gt;5mm, clinically significant papilledema, or reduced level of consciousness,&#xD;
             allergy to conductive coupling agent, gel, and other serious life-threatening&#xD;
             diseases.&#xD;
&#xD;
          -  Other circumstances considered inappropriate to participate in the research by the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhixiong Liu, M.D.</last_name>
    <phone>+8613607318785</phone>
    <email>zhixiongliu@csu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhixiong Liu, M.D.</last_name>
      <phone>+8613607318785</phone>
      <email>zhixiongliu@csu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glioblastoma</keyword>
  <keyword>tumor electric fields treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04417933
org study id: 202001012
nct id: NCT04417933
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This early phase I trial will investigate the safety and feasibility of applying the Tumor
      Electric Fields Treatment System to subjects with recurrent glioblastoma.
Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy
      with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields
      Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric
      Fields Treatment System to subjects with recurrent GBM.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: The treatment-related adverse events
time frame: 12 months
description: Number of patients who experienced a treatment-related adverse event.
measure: Time to Progression
time frame: 12 months
description: Time to progression of patients with recurrent glioblastoma.
measure: Overall Survival Rate
time frame: 12 months
description: Number of patients alive at 12 months.
arm group label: Tumor Electric Fields Treatment System
arm group type: Experimental
description: Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.
intervention type: Device
intervention name: Tumor Electric Fields Treatment System
description: Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.
arm group label: Tumor Electric Fields Treatment System
other name: ASCLU-300
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zhixiong Liu, M.D.
phone: +8613607318785
email: zhixiongliu@csu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Glioblastoma