<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/NCT03820310</url>
  </required_header>
  <id_info>
    <org_study_id>CH-IT-004</org_study_id>
    <nct_id>NCT03820310</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Autologous Tcm Immunotherapy in ICC</brief_title>
  <official_title>Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newish Technology (Beijing) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Newish Technology (Beijing) Co., Ltd.</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>
      The prime purpose of this trial is to evaluate the Progression Free survival and two-year&#xD;
      survival of combining autologous Tcm cellular immunotherapy and traditional therapy in&#xD;
      intrahepatic cholangiocarcinoma (ICC) patients after radical resection. A secondary objective&#xD;
      of the trial is to assess the long-term survival and safety of Tcm cellular immunotherapy and&#xD;
      traditional therapy in ICC patients after radical resection. Patients will be randomized 1:1&#xD;
      either to the experimental group to receive autologous Tcm cellular immunotherapy and&#xD;
      chemotherapy or to the control group (traditional therapy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrahepatic cholangiocarcinoma (ICC) accounts for 2%~3% of gastrointestinal tumors, and the&#xD;
      incidence has been on the rise globally. The pathogenesis of ICC remains unclearly. Compared&#xD;
      with palliative resection, the postoperative survival rate of patients undergoing radical&#xD;
      resection is significantly improved. However, most patients after radical resection will&#xD;
      recurrence or metastasis, and the five-year overall survival rate is about 10-40%.&#xD;
&#xD;
      Autologous cellular immunotherapy is to collect patient's own immune cells and infuse into&#xD;
      the patient's body after culture in vitro that can activate the anti-tumor immune response&#xD;
      and then achieve the purpose of cancer treatment. Central memory T cells (Tcm) is the most&#xD;
      effective anti-tumor immune cell with long-term in vivo survival and self-renewal capacity.&#xD;
      Combination of autologous cellular immunotherapy with traditional therapies, such as&#xD;
      radiotherapy or chemotherapy, can effectively prolong the survival period of patients, and&#xD;
      improve the quality of life for patients.&#xD;
&#xD;
      This study will recruit subjects with pathologically confirmed intrahepatic&#xD;
      cholangiocarcinoma after radical resection. Patients must have adequate hematologic and end&#xD;
      organ function, performance status and no contraindications to receive autologous cellular&#xD;
      immunotherapy.&#xD;
&#xD;
      The observation period of patients is 24 months. The prime purpose of this trial is to&#xD;
      evaluate the Progression Free Survival (PFS) and two-year survival of combining autologous&#xD;
      Tcm cellular immunotherapy and traditional therapy in intrahepatic cholangiocarcinoma (ICC)&#xD;
      patients after radical resection. A secondary objective of the trial is to assess the&#xD;
      long-term survival and safety of Tcm cellular immunotherapy and traditional therapy in ICC&#xD;
      patients after radical resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>Phase 2</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>Progression Free Survival</measure>
    <time_frame>24 months</time_frame>
    <description>The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Two-year survival</measure>
    <time_frame>24 months</time_frame>
    <description>Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The long-term survival of ICC subjects</measure>
    <time_frame>24 months</time_frame>
    <description>The long-term survival of ICC subjects treated with Tcm cellular immunotherapy and traditional therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>traditional therapy plus autologous Tcm cellular immunotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>traditional therapy alone, such as radiotherapy or chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous Tcm cellular immunotherapy</intervention_name>
    <description>autologous cellular immunotherapy plus traditional therapy. • cells will be infused in 3-5×109 cells/100 ml 1 month after radical resection, then cells will be infused as the same dose followed by a 1 month rest period, Each subject in experimental group will receive a total of 5 cell infusions.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be willing and able to provide written informed consent for the trial&#xD;
&#xD;
          2. Subjects treated with radical resection completely, and pathologically confirmed&#xD;
             intrahepatic cholangiocarcinoma&#xD;
&#xD;
          3. Subjects with image examination confirmed complete response (CR) postoperatively&#xD;
&#xD;
          4. Age between 18 and 70 years old&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          6. Normal hematopoietic function:&#xD;
&#xD;
             White Blood Cell (WBC) ≥ 4×10^9 /L Neutrophil ≥ 2×10^9 /L Hemoglobin ≥ 90 g /L&#xD;
             Platelets ≥ 100×10^9 /L&#xD;
&#xD;
          7. Lymphocyte ≥ 0.7×10^9 /L&#xD;
&#xD;
          8. Adequate Liver and kidney function Alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase (AST) ≤ 2.5 the upper limit of normal (ULN) for the institution Total&#xD;
             bilirubin (TBIL) ≤ 1.5 the upper limit of ULN Serum creatinine (CREA) ≤ 1.5 the upper&#xD;
             limit of ULN Creatinine clearance ≥ 70 ml/min&#xD;
&#xD;
          9. Subjects without significant cardiovascular and lung disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with recurrent intrahepatic cholangiocarcinoma&#xD;
&#xD;
          2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents&#xD;
             after organ transplantation.&#xD;
&#xD;
          3. Subjects with severe abnormality of coagulation;&#xD;
&#xD;
          4. History or any evidence of hemorrhage.&#xD;
&#xD;
          5. Subjects with bone marrow transplant or severe leukopenia&#xD;
&#xD;
          6. Subjects with severe heart, liver or kidney diseases.&#xD;
&#xD;
          7. Subjects with severe infection or high fever.&#xD;
&#xD;
          8. Subjects with severe autoimmune diseases.&#xD;
&#xD;
          9. Subjects infected with HIV&#xD;
&#xD;
         10. Subjects combined with other malignancies&#xD;
&#xD;
         11. Subjects with T-cell lymphma or tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shunda Du, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haifeng Xu, M.D</last_name>
    <phone>+86-13161554560</phone>
    <email>793433066@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiao-E Yan, Ph.D</last_name>
    <phone>+86-18210236948</phone>
    <email>yanxiaoe@newishes.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haifeng Xu, M.D</last_name>
      <phone>13161554560</phone>
      <email>793433066@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malignancy</keyword>
  <keyword>intrahepatic cholangiocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03820310
org study id: CH-IT-004
nct id: NCT03820310
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prime purpose of this trial is to evaluate the Progression Free survival and two-year
      survival of combining autologous Tcm cellular immunotherapy and traditional therapy in
      intrahepatic cholangiocarcinoma (ICC) patients after radical resection. A secondary objective
      of the trial is to assess the long-term survival and safety of Tcm cellular immunotherapy and
      traditional therapy in ICC patients after radical resection. Patients will be randomized 1:1
      either to the experimental group to receive autologous Tcm cellular immunotherapy and
      chemotherapy or to the control group (traditional therapy).
Intrahepatic cholangiocarcinoma (ICC) accounts for 2%~3% of gastrointestinal tumors, and the
      incidence has been on the rise globally. The pathogenesis of ICC remains unclearly. Compared
      with palliative resection, the postoperative survival rate of patients undergoing radical
      resection is significantly improved. However, most patients after radical resection will
      recurrence or metastasis, and the five-year overall survival rate is about 10-40%.

      Autologous cellular immunotherapy is to collect patient's own immune cells and infuse into
      the patient's body after culture in vitro that can activate the anti-tumor immune response
      and then achieve the purpose of cancer treatment. Central memory T cells (Tcm) is the most
      effective anti-tumor immune cell with long-term in vivo survival and self-renewal capacity.
      Combination of autologous cellular immunotherapy with traditional therapies, such as
      radiotherapy or chemotherapy, can effectively prolong the survival period of patients, and
      improve the quality of life for patients.

      This study will recruit subjects with pathologically confirmed intrahepatic
      cholangiocarcinoma after radical resection. Patients must have adequate hematologic and end
      organ function, performance status and no contraindications to receive autologous cellular
      immunotherapy.

      The observation period of patients is 24 months. The prime purpose of this trial is to
      evaluate the Progression Free Survival (PFS) and two-year survival of combining autologous
      Tcm cellular immunotherapy and traditional therapy in intrahepatic cholangiocarcinoma (ICC)
      patients after radical resection. A secondary objective of the trial is to assess the
      long-term survival and safety of Tcm cellular immunotherapy and traditional therapy in ICC
      patients after radical resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 24 months
description: The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
measure: Two-year survival
time frame: 24 months
description: Two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
measure: The long-term survival of ICC subjects
time frame: 24 months
description: The long-term survival of ICC subjects treated with Tcm cellular immunotherapy and traditional therapy.
arm group label: Experimental group
arm group type: Experimental
description: traditional therapy plus autologous Tcm cellular immunotherapy.
arm group label: control group
arm group type: No Intervention
description: traditional therapy alone, such as radiotherapy or chemotherapy.
intervention type: Biological
intervention name: autologous Tcm cellular immunotherapy
description: autologous cellular immunotherapy plus traditional therapy. • cells will be infused in 3-5×109 cells/100 ml 1 month after radical resection, then cells will be infused as the same dose followed by a 1 month rest period, Each subject in experimental group will receive a total of 5 cell infusions.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shunda Du, M.D
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Haifeng Xu, M.D
phone: +86-13161554560
email: 793433066@qq.com
last name: Xiao-E Yan, Ph.D
phone: +86-18210236948
email: yanxiaoe@newishes.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Immunomodulating Agents
sharing ipd: No