<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/NCT03011255</url>
  </required_header>
  <id_info>
    <org_study_id>HangzhouCH06</org_study_id>
    <nct_id>NCT03011255</nct_id>
  </id_info>
  <brief_title>Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer</brief_title>
  <official_title>Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shixiu Wu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hangzhou Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Immunotherapy is now considered to be one of promising approaches for treating cancer.&#xD;
      Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal&#xD;
      cancer. Radiation-induced mutation genes were identified as new sources of tumor associated&#xD;
      antigens using exon sequencing and peptide microarray technologies. Epitope peptides for&#xD;
      these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this&#xD;
      clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL&#xD;
      therapy in combination with radiation therapy in treating patients with unresectable,&#xD;
      advanced or recurrent esophageal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2</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>Local control</measure>
    <time_frame>two years after enrollment</time_frame>
    <description>occurrence of local or regional progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate as assessed by RECIST criteria</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <condition>Esophageal Diseases</condition>
  <condition>Digestive System Diseases</condition>
  <arm_group>
    <arm_group_label>peptide specific CTL arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>peptide specific CTL, radiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>peptide specific CTL</intervention_name>
    <description>Radiation: RT to 60 Gy, 5 x per week，for 6 weeks Biological: Peptide specific CTL Peptide specific CTL will be administered by intravenous injection on day 28 of radiation.</description>
    <arm_group_label>peptide specific CTL arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have unresectable, locally advanced, recurrent disease of esophageal&#xD;
             cancer. Histologically confirmed cancer of the esophagus.&#xD;
&#xD;
          2. measurable disease by CT scan&#xD;
&#xD;
          3. ECOG performance status of 0 to 2&#xD;
&#xD;
          4. Expected survival of at least 3months&#xD;
&#xD;
          5. Laboratory values as follow:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1.5×109&#xD;
&#xD;
               -  White blood cell count ≥ 3×109/L&#xD;
&#xD;
               -  Platelets ≥ 100×109/L&#xD;
&#xD;
               -  Haemoglobin (Hb) ≥ 10g/dL (patients'Hb should be corrected to &gt;10g/dL before&#xD;
                  treatment)&#xD;
&#xD;
               -  Adequate liver function (within 1 week prior to randomization)&#xD;
&#xD;
               -  Serum bilirubin ≤ 1.5× ULN&#xD;
&#xD;
               -  Alanine aminotransferase/aspartate transaminase (ALT / AST) ≤ 2.5× ULN&#xD;
&#xD;
               -  Alkaline phosphatase (ALP) ≤ 3× ULN&#xD;
&#xD;
          6. Able and willing to give valid written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means&#xD;
             of contraception)&#xD;
&#xD;
          2. Breastfeeding&#xD;
&#xD;
          3. Active or uncontrolled infection&#xD;
&#xD;
          4. Prior chemotherapy, radiation therapy or immunotherapy&#xD;
&#xD;
          5. Concurrent treatment with steroid or immunosuppressing agent&#xD;
&#xD;
          6. Patient with peptic ulcer disease&#xD;
&#xD;
          7. Other malignancy within 5 years prior to entry into the study, expect for treated&#xD;
             non-melanoma skin cancer and cervical carcinoma in situ&#xD;
&#xD;
          8. Disease to the central nervous system&#xD;
&#xD;
          9. Decision of unsuitableness by principal investigator or physician-in-charge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hangzhou Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shixiu Wu, MD</last_name>
      <phone>+8657186826086</phone>
      <email>wushixiu@medmail.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hangzhou Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Shixiu Wu</investigator_full_name>
    <investigator_title>director of the hospital</investigator_title>
  </responsible_party>
  <keyword>Esophageal cancer</keyword>
  <keyword>Peptide specific CTL</keyword>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Esophageal Diseases</mesh_term>
  </condition_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/NCT03011255
org study id: HangzhouCH06
nct id: NCT03011255
lead sponsor: 
has dmc: Yes
Immunotherapy is now considered to be one of promising approaches for treating cancer.
      Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal
      cancer. Radiation-induced mutation genes were identified as new sources of tumor associated
      antigens using exon sequencing and peptide microarray technologies. Epitope peptides for
      these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this
      clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL
      therapy in combination with radiation therapy in treating patients with unresectable,
      advanced or recurrent esophageal cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control
time frame: two years after enrollment
description: occurrence of local or regional progression
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 3 months
description: Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
measure: Objective response rate as assessed by RECIST criteria
time frame: 3 months
measure: Time to progression
time frame: 1 year
measure: Overall survival
time frame: 1 year
arm group label: peptide specific CTL arm
arm group type: Experimental
description: peptide specific CTL, radiation
intervention type: Biological
intervention name: peptide specific CTL
description: Radiation: RT to 60 Gy, 5 x per week，for 6 weeks Biological: Peptide specific CTL Peptide specific CTL will be administered by intravenous injection on day 28 of radiation.
arm group label: peptide specific CTL arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hangzhou Cancer Hospital
investigator full name: Shixiu Wu
investigator title: director of the hospital
mesh term: Esophageal Neoplasms
mesh term: Digestive System Diseases
mesh term: Gastrointestinal Diseases
mesh term: Esophageal Diseases
sharing ipd: No