xml: <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/NCT06014372</url>
    </required_header>
    <id_info>
      <org_study_id>2022-FXY-256-Department of CRC</org_study_id>
      <nct_id>NCT06014372</nct_id>
    </id_info>
    <brief_title>Envolimab Monotherapy or Envolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer</brief_title>
    <official_title>A Prospective, Single-center, Multi-cohort Study of Envolimab Monotherapy or Envolimab in Combination With CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR&#xD;
        colorectal cancer can derive benefits from immunotherapy in the management of advanced&#xD;
        colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite&#xD;
        instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy,&#xD;
        resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial&#xD;
        exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic&#xD;
        effect of neoadjuvant immunotherapy in this particular patient population. Envality&#xD;
        monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses&#xD;
        noteworthy practical and societal value in the context of exploratory clinical research on&#xD;
        neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The&#xD;
        objective of this study is to evaluate the safety and efficacy of Envality monoclonal&#xD;
        antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer&#xD;
        through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to&#xD;
        investigate the effectiveness and safety of Envality monoclonal antibody in combination with&#xD;
        CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of pCR</measure>
      <time_frame>Time Frame: One week after surgery</time_frame>
      <description>rate of pathological complete remission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DFS</measure>
      <time_frame>3 years</time_frame>
      <description>Disease free survival</description>
    </secondary_outcome>
    <other_outcome>
      <measure>OS</measure>
      <time_frame>5 years</time_frame>
      <description>O Overall survival</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Colon Cancer</condition>
    <condition>Neoadjuvant Therapy</condition>
    <condition>Immunotherapy</condition>
    <arm_group>
      <arm_group_label>Envafolimab Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients diagnosed with colon cancer, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colon cancer, will be enrolled in Group A</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Envafolimab+CAPEOX Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients diagnosed with colon adenocarcinoma, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite stable (MSS)/proficient mismatch repair (pMMR) colon cancer, will be enrolled in Group B.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Envafolimab</intervention_name>
      <description>Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.</description>
      <arm_group_label>Envafolimab Group</arm_group_label>
      <arm_group_label>Envafolimab+CAPEOX Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CAPEOX</intervention_name>
      <description>The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2, administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks; and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every 3 weeks, for a total of 4 cycles.</description>
      <arm_group_label>Envafolimab+CAPEOX Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathological confirmed rectal cancer&#xD;
  &#xD;
            -  Clinical stage T3-4 or T any N1&#xD;
  &#xD;
            -  With or without MRF positivity, with or without EMVI positivity&#xD;
  &#xD;
            -  R0 resection is estimated&#xD;
  &#xD;
            -  Age ranged from 18 to 70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinical stage T1-2 N0&#xD;
  &#xD;
            -  Distance metastasis&#xD;
  &#xD;
            -  Multiple primary tumor&#xD;
  &#xD;
            -  Cachexy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhenhai Lu, Prof</last_name>
      <phone>+862087343584</phone>
      <email>luzhh@sysucc.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rongxin Zhang, Prof</last_name>
      <phone>+862087343584</phone>
      <email>zhangrx@sysucc.org.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sun Yat-Sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhen-Hai Lu, Prof.</last_name>
        <phone>+86 20 87343584</phone>
        <email>luzhh@sysucc.org.cn</email>
      </contact>
      <contact_backup>
        <last_name>Rong-Xin Zhang, Prof.</last_name>
        <phone>+86 20 87343456</phone>
        <email>zhangrx@sysucc.org.cn</email>
      </contact_backup>
      <investigator>
        <last_name>Zhen-Hai Lu, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rong-Xin Zhang, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zhi-Qiang Wang, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yuan Li, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fu-Long Wang, M.D</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jian-Hong Peng, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jia-Li Chen, Bachelor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Wei-Li Zhang, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Zhen-Hai Lu</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014372
  org study id: 2022-FXY-256-Department of CRC
  nct id: NCT06014372
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR
        colorectal cancer can derive benefits from immunotherapy in the management of advanced
        colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite
        instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy,
        resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial
        exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic
        effect of neoadjuvant immunotherapy in this particular patient population. Envality
        monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses
        noteworthy practical and societal value in the context of exploratory clinical research on
        neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The
        objective of this study is to evaluate the safety and efficacy of Envality monoclonal
        antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer
        through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to
        investigate the effectiveness and safety of Envality monoclonal antibody in combination with
        CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of pCR
  time frame: Time Frame: One week after surgery
  description: rate of pathological complete remission
  measure: DFS
  time frame: 3 years
  description: Disease free survival
  measure: OS
  time frame: 5 years
  description: O Overall survival
  arm group label: Envafolimab Group
  arm group type: Experimental
  description: Patients diagnosed with colon cancer, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colon cancer, will be enrolled in Group A
  arm group label: Envafolimab+CAPEOX Group
  arm group type: Active Comparator
  description: Patients diagnosed with colon adenocarcinoma, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite stable (MSS)/proficient mismatch repair (pMMR) colon cancer, will be enrolled in Group B.
  intervention type: Drug
  intervention name: Envafolimab
  description: Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.
  arm group label: Envafolimab Group
  arm group label: Envafolimab+CAPEOX Group
  intervention type: Drug
  intervention name: CAPEOX
  description: The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2, administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks; and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every 3 weeks, for a total of 4 cycles.
  arm group label: Envafolimab+CAPEOX Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhenhai Lu, Prof
  phone: +862087343584
  email: luzhh@sysucc.org.cn
  last name: Rongxin Zhang, Prof
  phone: +862087343584
  email: zhangrx@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Zhen-Hai Lu
  investigator title: Prof.
  mesh term: Colorectal Neoplasms