<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/NCT01691625</url>
  </required_header>
  <id_info>
    <org_study_id>JR-01</org_study_id>
    <nct_id>NCT01691625</nct_id>
  </id_info>
  <brief_title>Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer</brief_title>
  <official_title>Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to show if the adoptive cellular therapy with autologous&#xD;
      dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent&#xD;
      chemoradiation could improve the quality of life of the patients with locally advanced&#xD;
      esophageal cancer, compared with concurrent chemoradiation only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>the quality of life</measure>
    <time_frame>initial assessment, months 1, 3, 6 and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Immunological assessment</measure>
    <time_frame>baseline, months 1, 3, 6 and 12</time_frame>
    <description>Cytokine secretion and T cell populations are assessed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophageal Carcinoma</condition>
  <arm_group>
    <arm_group_label>concurrent chemoradiotherapy plus DC-CIK immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concurrent chemoradiation only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive concurrent chemoradiotherapy only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>concurrent chemoradiotherapy plus DC-CIK immunotherapy</intervention_name>
    <description>Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.&#xD;
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.&#xD;
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.</description>
    <arm_group_label>concurrent chemoradiotherapy plus DC-CIK immunotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Concurrent chemoradiation only</intervention_name>
    <description>Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.&#xD;
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.</description>
    <arm_group_label>Concurrent chemoradiation only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cytologically or histologically confirmed locally advanced esophageal carcinoma&#xD;
&#xD;
          -  Age: &gt; 18&#xD;
&#xD;
          -  Karnofsky performance status ≥ 70&#xD;
&#xD;
          -  At least one measurable tumor lesions according to the RECIST criteria.&#xD;
&#xD;
          -  Normal functions of heart, lung, liver, kidney and bone marrow&#xD;
&#xD;
          -  Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl,&#xD;
             neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic disease in the central nervous system (CNS).&#xD;
&#xD;
          -  Patients who are pregnant or nursing.&#xD;
&#xD;
          -  Patients with poor bone marrow, liver and kidney functions, which would make&#xD;
             chemotherapy intolerable&#xD;
&#xD;
          -  Patients with contraindication for irradiation: complete obstruction of esophagus,&#xD;
             deep esophageal ulcer, fistula to mediastinum, or haematemesis&#xD;
&#xD;
          -  coexisted morbidities that investigators believed not suitable for chemoradiation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Ren, MD, PhD</last_name>
    <phone>86-10-63926317</phone>
    <email>renjun9688@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Capital Medical University Cancer Center</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Ren, MD, PhD</last_name>
      <phone>86-10-63926317</phone>
      <email>renjun9688@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Jun Ren, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jun Ren MD, PhD</investigator_full_name>
    <investigator_title>Director,Capital Medical University (CMU)Cancer Center,</investigator_title>
  </responsible_party>
  <keyword>Locally advanced esophageal carcinoma</keyword>
  <keyword>DC-CIK</keyword>
  <keyword>Immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</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>
  <!-- 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/NCT01691625
org study id: JR-01
nct id: NCT01691625
lead sponsor: 
has dmc: No
The purpose of this study is to show if the adoptive cellular therapy with autologous
      dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent
      chemoradiation could improve the quality of life of the patients with locally advanced
      esophageal cancer, compared with concurrent chemoradiation only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the quality of life
time frame: initial assessment, months 1, 3, 6 and 12
measure: progression-free survival
time frame: 1 year
measure: Immunological assessment
time frame: baseline, months 1, 3, 6 and 12
description: Cytokine secretion and T cell populations are assessed.
arm group label: concurrent chemoradiotherapy plus DC-CIK immunotherapy
arm group type: Experimental
description: patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
arm group label: Concurrent chemoradiation only
arm group type: Active Comparator
description: patients will receive concurrent chemoradiotherapy only
intervention type: Other
intervention name: concurrent chemoradiotherapy plus DC-CIK immunotherapy
description: Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.
arm group label: concurrent chemoradiotherapy plus DC-CIK immunotherapy
intervention type: Other
intervention name: Concurrent chemoradiation only
description: Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
arm group label: Concurrent chemoradiation only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Ren, MD, PhD
phone: 86-10-63926317
email: renjun9688@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jun Ren MD, PhD
investigator title: Director,Capital Medical University (CMU)Cancer Center,
mesh term: Esophageal Neoplasms
mesh term: Immunomodulating Agents