<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/NCT04506138</url>
  </required_header>
  <id_info>
    <org_study_id>ZJCH-2020183-II-ESCC</org_study_id>
    <nct_id>NCT04506138</nct_id>
  </id_info>
  <brief_title>Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer 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 aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for&#xD;
      resectable thoracic esophageal squamous cell carcinoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <phase>Phase 1/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>Pathologic complete remission (PCR)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Pathologic Response (MPR)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival（EFS）</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>EQ-5D-3L questionnaire</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>FACT-E questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Camrelizumab plus Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Camrelizumab 200mg D1, D22</description>
    <arm_group_label>Camrelizumab plus Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel for Injection (Albumin Bound)</intervention_name>
    <description>Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29</description>
    <arm_group_label>Camrelizumab plus Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin AUC5 D1, D22</description>
    <arm_group_label>Camrelizumab plus Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of thoracic Esophageal squamous cell carcinoma&#xD;
&#xD;
          -  ECOG performance status 0-1&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
          -  Resectable disease, cT2-4aNanyM0 or cT1-3N+M0&#xD;
&#xD;
          -  Life expectancy more than 6 months&#xD;
&#xD;
          -  Use of an effective contraceptive for adults to prevent pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not suitable for surgery&#xD;
&#xD;
          -  Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC&#xD;
&#xD;
          -  Prior esophageal, gastric, or gastro-esophageal junction surgery&#xD;
&#xD;
          -  Esophageal ulcer, esophageal perforation，chest pain（≥middle level）&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>December 12, 2021</last_update_submitted>
  <last_update_submitted_qc>December 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Chenqixun</investigator_full_name>
    <investigator_title>Director of Thoracic Surgery Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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/NCT04506138
org study id: ZJCH-2020183-II-ESCC
nct id: NCT04506138
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for
      resectable thoracic esophageal squamous cell carcinoma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic complete remission (PCR)
time frame: 12 weeks
measure: Major Pathologic Response (MPR)
time frame: 12 weeks
measure: Overall Survival (OS)
time frame: 5 years
measure: Event Free Survival（EFS）
time frame: 5 years
measure: EQ-5D-3L questionnaire
time frame: 5 years
measure: FACT-E questionnaire
time frame: 5 years
description: Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E)
arm group label: Camrelizumab plus Chemotherapy
arm group type: Experimental
intervention type: Drug
intervention name: Camrelizumab
description: Camrelizumab 200mg D1, D22
arm group label: Camrelizumab plus Chemotherapy
intervention type: Drug
intervention name: Paclitaxel for Injection (Albumin Bound)
description: Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
arm group label: Camrelizumab plus Chemotherapy
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin AUC5 D1, D22
arm group label: Camrelizumab plus Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang Cancer Hospital
investigator full name: Chenqixun
investigator title: Director of Thoracic Surgery Department
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: No