<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/NCT04426955</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1210-III-323</org_study_id>
    <nct_id>NCT04426955</nct_id>
  </id_info>
  <brief_title>Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial,&#xD;
      comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive&#xD;
      chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in&#xD;
      China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, eligible subjects will be randomized into study arm or control arm.&#xD;
      Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The&#xD;
      chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS)&#xD;
      assessed by the Independent Review Committee (IRC) will be the primary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFS assessed by IRC</measure>
    <time_frame>up to 3 years</time_frame>
    <description>based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS assessed by investigators</measure>
    <time_frame>up to 3 years</time_frame>
    <description>based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>up to 3 years</time_frame>
    <description>OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DoR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>up to 3 years</time_frame>
    <description>adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">396</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo + Paclitaxel + Cisplatin + Radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>SHR-1210</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Concurrent Radiation</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable&#xD;
        and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1;&#xD;
        5.Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Indicators of severe malnutrition;&#xD;
&#xD;
          2. A history of surgery for esophageal cancer;&#xD;
&#xD;
          3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring&#xD;
             frequent drainage or medical intervention;&#xD;
&#xD;
          4. Known to be intolerable or resistant to treatment with the protocol-specified&#xD;
             chemotherapy;&#xD;
&#xD;
          5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology&#xD;
             therapies;&#xD;
&#xD;
          6. Active autoimmune diseases or history of autoimmune diseases that may relapse&#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>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PD-1Antibody</keyword>
  <keyword>locally advanced esophageal cancer</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>Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</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/NCT04426955
org study id: SHR-1210-III-323
nct id: NCT04426955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial,
      comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive
      chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in
      China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subjects will be randomized into study arm or control arm.
      Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The
      chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS)
      assessed by the Independent Review Committee (IRC) will be the primary outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PFS assessed by IRC
time frame: up to 3 years
description: based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
measure: PFS assessed by investigators
time frame: up to 3 years
description: based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
measure: OS
time frame: up to 3 years
description: OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
measure: ORR
time frame: up to 3 years
description: based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
measure: DoR
time frame: up to 3 years
description: based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
measure: AE
time frame: up to 3 years
description: adverse events
arm group label: Arm A
arm group type: Experimental
description: Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
arm group label: Arm B
arm group type: Placebo Comparator
description: Placebo + Paclitaxel + Cisplatin + Radiotherapy.
intervention type: Drug
intervention name: Camrelizumab
description: IV infusion
arm group label: Arm A
other name: SHR-1210
intervention type: Drug
intervention name: Paclitaxel
description: IV infusion
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Cisplatin
description: IV infusion
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Placebo
description: IV infusion
arm group label: Arm B
intervention type: Radiation
intervention name: Radiation
description: Concurrent Radiation
arm group label: Arm A
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel
mesh term: Cisplatin
sharing ipd: No