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/NCT06037655</url>
    </required_header>
    <id_info>
      <org_study_id>MA-BTC-II-002</org_study_id>
      <nct_id>NCT06037655</nct_id>
    </id_info>
    <brief_title>Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC</brief_title>
    <acronym>Modified</acronym>
    <official_title>Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</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>
        The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin&#xD;
        combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially&#xD;
        resectable Biliary Tract Neoplasms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, patients giving written informed&#xD;
        consent will undergo a 1-week screening period to determine eligibility for study entry. At&#xD;
        week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin&#xD;
        combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed&#xD;
        after 4 cycles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2026</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>Objective response rate (ORR)</measure>
      <time_frame>18 weeks</time_frame>
      <description>ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>overall survival (OS)</measure>
      <time_frame>2 years</time_frame>
      <description>Overall survival</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>2 years</time_frame>
      <description>PFS is defined as time interval from recruitment to tumor progression or censoring</description>
    </other_outcome>
    <other_outcome>
      <measure>Pathological Complete Response Rate (pCR)</measure>
      <time_frame>18 weeks</time_frame>
      <description>pathological complete response rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Major Pathological Response Rate (MPR)</measure>
      <time_frame>18 weeks</time_frame>
      <description>MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Biliary Tract Neoplasms</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Total Neoadjuvant Treatment</intervention_name>
      <description>Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age ≥ 18 years，≤ 75 years&#xD;
  &#xD;
            -  Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are&#xD;
               difficult to directly resecte surgically&#xD;
  &#xD;
            -  Ability to provide written informed consent prior to participation in any&#xD;
               study-related procedure&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
  &#xD;
            -  At least one, not previously irradiated, measurable lesion according to RECIST&#xD;
               (version 1.1).&#xD;
  &#xD;
            -  Adequate organ function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma&#xD;
  &#xD;
            -  Known history of a serious allergy to any monoclonal antibody&#xD;
  &#xD;
            -  Any active malignancy prior to the start of treatment&#xD;
  &#xD;
            -  Active or history of autoimmune disease&#xD;
  &#xD;
            -  Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities&#xD;
               that may increase the risk of study participation&#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>
    <overall_official>
      <last_name>Xiangcheng Li</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xiaofeng Chen</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiangcheng Li</last_name>
      <phone>18951999088</phone>
      <email>drlixc@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiaofeng Chen</last_name>
      <phone>13585172066</phone>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Biliary Tract Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06037655
  org study id: MA-BTC-II-002
  nct id: NCT06037655
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin
        combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially
        resectable Biliary Tract Neoplasms.
  After being informed about the study and potential risks, patients giving written informed
        consent will undergo a 1-week screening period to determine eligibility for study entry. At
        week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin
        combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed
        after 4 cycles.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: 18 weeks
  description: ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
  measure: overall survival (OS)
  time frame: 2 years
  description: Overall survival
  measure: Progression free survival (PFS)
  time frame: 2 years
  description: PFS is defined as time interval from recruitment to tumor progression or censoring
  measure: Pathological Complete Response Rate (pCR)
  time frame: 18 weeks
  description: pathological complete response rate
  measure: Major Pathological Response Rate (MPR)
  time frame: 18 weeks
  description: MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
  arm group label: Experimental
  arm group type: Experimental
  description: NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
  intervention type: Drug
  intervention name: Total Neoadjuvant Treatment
  description: Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xiangcheng Li
  role: Study Chair
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Xiaofeng Chen
  role: Principal Investigator
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Xiangcheng Li
  phone: 18951999088
  email: drlixc@163.com
  last name: Xiaofeng Chen
  phone: 13585172066
  responsible party type: Sponsor
  mesh term: Biliary Tract Neoplasms
  sharing ipd: No