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/NCT06011330</url>
    </required_header>
    <id_info>
      <org_study_id>FRUPD-1</org_study_id>
      <nct_id>NCT06011330</nct_id>
    </id_info>
    <brief_title>Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer</brief_title>
    <official_title>Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hunan Cancer Hospital</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>
        The survival of the refractory CRC is dismal and therapy options are limited ，the researchers&#xD;
        aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in&#xD;
        refractory MSS metastatic colorectal cancer in a real-world setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The invesgators conducted a retrospective single arm, single-center study in which patients&#xD;
        with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after&#xD;
        progressed at least two lines of standard chemotherapy with or without targeted drugs such as&#xD;
        bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June&#xD;
        2022. Eligible patients were aged 18 years or older and had histologically or cytologically&#xD;
        confirmed adenocarcinoma of the colon or rectum; with patients who have at least one&#xD;
        non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors&#xD;
        (RECIST version 1.1).The primary endpoint was overall survival (OS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Actual">February 10, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>overall survival (OS)</measure>
      <time_frame>assessed up to 2 year</time_frame>
      <description>Overall survival defined as the observed time from the treatment of the study until death due to any cause</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>progress-free survival (PFS)</measure>
      <time_frame>assessed up to 1 year</time_frame>
      <description>the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>objective response rate (ORR)</measure>
      <time_frame>assessed up to 1 year</time_frame>
      <description>The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment</description>
    </other_outcome>
    <other_outcome>
      <measure>disease control rate (DCR)</measure>
      <time_frame>assessed up to 1 year</time_frame>
      <description>Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1</description>
    </other_outcome>
    <other_outcome>
      <measure>Treatment-Related Adverse Events (TRAE)</measure>
      <time_frame>assessed up to 1 year</time_frame>
      <description>Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">70</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <description>fruquintinib combined with anti-PD-1 antibodies</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fruquintinib combined with anti-PD-1 antibodies</intervention_name>
      <description>Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).</description>
      <arm_group_label>study group</arm_group_label>
      <other_name>programmed cell death protein 1</other_name>
      <other_name>immune checkpoint inhibitor</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Refractory MSS Metastatic Colorectal Cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with MSS/pMMR mCRC who have been received Fruquintinib combined with&#xD;
               anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with&#xD;
               or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer&#xD;
               Hospital from 1th January 2019 to 30th June 2022;&#xD;
  &#xD;
            2. Eligible patients were aged 18 years or older&#xD;
  &#xD;
            3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;&#xD;
  &#xD;
            4. patients who have at least one non-resectable measurable lesion to evaluate by&#xD;
               response evaluation criteria in solid tumors (RECIST version 1.1).&#xD;
  &#xD;
            5. an Eastern Cooperative Oncology Group performance status of 0-2;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy, lactating female or possibility of becoming pregnant during the study.&#xD;
  &#xD;
            2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of&#xD;
               previous anticancer therapy (excluding alopecia, and skin pigmentation).&#xD;
  &#xD;
            3. Has symptomatic central nervous system metastases that are neurologically unstable or&#xD;
               requiring increasing doses of steroids to control CNS disease.&#xD;
  &#xD;
            4. Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV&#xD;
               antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or&#xD;
               symptomatic arrhythmia.&#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>Hunan Cancer Hospital</name>
        <address>
          <city>ChangSha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fruquintinib</keyword>
    <keyword>PD-1</keyword>
    <keyword>pMMR/MSS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
      <mesh_term>Antibodies</mesh_term>
    </intervention_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/NCT06011330
  org study id: FRUPD-1
  nct id: NCT06011330
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The survival of the refractory CRC is dismal and therapy options are limited ，the researchers
        aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in
        refractory MSS metastatic colorectal cancer in a real-world setting.
  The invesgators conducted a retrospective single arm, single-center study in which patients
        with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after
        progressed at least two lines of standard chemotherapy with or without targeted drugs such as
        bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June
        2022. Eligible patients were aged 18 years or older and had histologically or cytologically
        confirmed adenocarcinoma of the colon or rectum; with patients who have at least one
        non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors
        (RECIST version 1.1).The primary endpoint was overall survival (OS).
  observational model: Cohort
  time perspective: Retrospective
  measure: overall survival (OS)
  time frame: assessed up to 2 year
  description: Overall survival defined as the observed time from the treatment of the study until death due to any cause
  measure: progress-free survival (PFS)
  time frame: assessed up to 1 year
  description: the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
  measure: objective response rate (ORR)
  time frame: assessed up to 1 year
  description: The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment
  measure: disease control rate (DCR)
  time frame: assessed up to 1 year
  description: Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1
  measure: Treatment-Related Adverse Events (TRAE)
  time frame: assessed up to 1 year
  description: Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
  arm group label: study group
  description: fruquintinib combined with anti-PD-1 antibodies
  intervention type: Drug
  intervention name: Fruquintinib combined with anti-PD-1 antibodies
  description: Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).
  arm group label: study group
  other name: programmed cell death protein 1
  other name: immune checkpoint inhibitor
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Immune Checkpoint Inhibitors
  mesh term: Antibodies
  sharing ipd: No