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/NCT06010667</url>
    </required_header>
    <id_info>
      <org_study_id>Zhengmao ZHANG</org_study_id>
      <nct_id>NCT06010667</nct_id>
    </id_info>
    <brief_title>A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer</brief_title>
    <official_title>A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hebei Medical University Fourth Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hebei Medical University Fourth Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to evaluate the efficacy and safety of&#xD;
        cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of&#xD;
        recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal&#xD;
        cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>overall response rate;ORR</measure>
      <time_frame>2years</time_frame>
      <description>CR+PR</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Epithelial Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>EBC</arm_group_label>
      <description>cyclophosphamide and bevacizumab in combination with Envafolimab</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BC</arm_group_label>
      <description>cyclophosphamide in combination with Envafolimab</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Envafolimab</intervention_name>
      <description>With or without Envafolimab</description>
      <arm_group_label>EBC</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-70 years Histologically or pathologically confirmed epithelial ovarian cancer&#xD;
               (EOC), fallopian tube cancer, primary peritoneal cancer Patients with recurrent&#xD;
               ovarian, fallopian tube, and primary peritoneal cancer following platinum-based&#xD;
               chemotherapy measurable lesions (according to RECIST 1.1 criteria, non-lymph node&#xD;
               lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15&#xD;
               mm) ECOG PS score: 0 - 1;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject has prior or concurrent other malignancy Prior treatment with other&#xD;
               PD-L1/PD-L1 inhibitors cannot be enrolled; Subject has known previous hypersensitivity&#xD;
               to macromolecular protein preparations or applied drug components&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>zhengmao zhang, Chief Physician</last_name>
      <phone>13933129926</phone>
      <email>1356606@vip.sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hebei</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050300</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
      <mesh_term>Fallopian Tube 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/NCT06010667
  org study id: Zhengmao ZHANG
  nct id: NCT06010667
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to evaluate the efficacy and safety of
        cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of
        recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal
        cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: overall response rate;ORR
  time frame: 2years
  description: CR+PR
  arm group label: EBC
  description: cyclophosphamide and bevacizumab in combination with Envafolimab
  arm group label: BC
  description: cyclophosphamide in combination with Envafolimab
  intervention type: Drug
  intervention name: Envafolimab
  description: With or without Envafolimab
  arm group label: EBC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: zhengmao zhang, Chief Physician
  phone: 13933129926
  email: 1356606@vip.sina.com
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Fallopian Tube Neoplasms
  sharing ipd: No