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/NCT06031376</url>
    </required_header>
    <id_info>
      <org_study_id>FPTB-01</org_study_id>
      <nct_id>NCT06031376</nct_id>
    </id_info>
    <brief_title>Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC</brief_title>
    <official_title>Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC: A Retrospective Cohort Study Based on Propensity Score Matching</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>
        Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common&#xD;
        therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However,&#xD;
        it's still not clear that which therapy can bring better prognosis. Our study sought to&#xD;
        investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with&#xD;
        bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the&#xD;
        Hunan Cancer Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with&#xD;
        mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS)&#xD;
        would be calculated to balance the baseline characteristics of two arms. Overall survival&#xD;
        (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in&#xD;
        total were enrolled. According to the treatment received, 72 and 34 pts were respectively&#xD;
        allocated into FP cohort and TB cohort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2019</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">October 31, 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>Approximately 12 months</time_frame>
      <description>Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Approximately 12 months</time_frame>
      <description>Progression-free survival defined as the time elapsed between the date of commencement of treatment and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>Approximately 12 months</time_frame>
      <description>Overall response rate (ORR) was regarded as the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Approximately 12 months</time_frame>
      <description>Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-Related Adverse Events (TRAE)</measure>
      <time_frame>Approximately 12 months</time_frame>
      <description>Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">106</enrollment>
    <condition>Metastatic Colorectal Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Fruquintinib plus PD-1 inhibitors</arm_group_label>
      <description>In fruquintinib plus PD-1 inhibitors group,The patients were treated orally with Fruquintinib (5mg once daily for 14 days on/7 days off, over a 21-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAS-102 plus bevacizumab</arm_group_label>
      <description>In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fruquintinib</intervention_name>
      <description>5mg once daily for 14 days on/7 days off, over a 21-day cycle</description>
      <arm_group_label>Fruquintinib plus PD-1 inhibitors</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PD-1 inhibitors</intervention_name>
      <description>The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.</description>
      <arm_group_label>Fruquintinib plus PD-1 inhibitors</arm_group_label>
      <other_name>anti-PD-1 antibodies</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trifluridine/Tipiracil</intervention_name>
      <description>TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days</description>
      <arm_group_label>TAS-102 plus bevacizumab</arm_group_label>
      <other_name>TAS-102</other_name>
      <other_name>Lonsurf</other_name>
      <other_name>S 95005</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab</intervention_name>
      <description>Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days</description>
      <arm_group_label>TAS-102 plus bevacizumab</arm_group_label>
      <other_name>Avastin</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Study population were the patients treated with at least 2 cycle of fruquintinib plus PD-1&#xD;
          Inhibitors or TAS-102 plus BEV in patients suffering refractory mCRC from July 2019 to&#xD;
          October 2022 at the Hunan Cancer Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all&#xD;
               other histological types are excluded).&#xD;
  &#xD;
            2. Have progressed from at least 2 lines of standard treatment,including&#xD;
               fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like&#xD;
               bevacizumab and cetuximab (only for RAS wild-type). Regorafenib was permitted but not&#xD;
               required for inclusion.&#xD;
  &#xD;
            3. Has measurable or non-measurable disease as defined by RECIST version 1.1&#xD;
  &#xD;
            4. Is able to swallow oral tablets.&#xD;
  &#xD;
            5. Estimated life expectancy ≥12 weeks.&#xD;
  &#xD;
            6. Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2&#xD;
  &#xD;
            7. Has adequate organ function.&#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.&#xD;
  &#xD;
            5. Known carriers of HIV antibodies.&#xD;
  &#xD;
            6. Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic&#xD;
               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>
    <overall_official>
      <last_name>Rongrong li, professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hunan Cancer Hospital</affiliation>
    </overall_official>
    <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>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colorectal cancer; Fruquintinib;PD-1;TAS-102; bevacizumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trifluridine</mesh_term>
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for principal investigator or correspondence author]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>please contact the principal investigator of this study or correspondence author.</ipd_access_criteria>
    </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/NCT06031376
  org study id: FPTB-01
  nct id: NCT06031376
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common
        therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However,
        it's still not clear that which therapy can bring better prognosis. Our study sought to
        investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with
        bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the
        Hunan Cancer Hospital.
  This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with
        mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS)
        would be calculated to balance the baseline characteristics of two arms. Overall survival
        (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in
        total were enrolled. According to the treatment received, 72 and 34 pts were respectively
        allocated into FP cohort and TB cohort.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall Survival (OS)
  time frame: Approximately 12 months
  description: Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause
  measure: Progression-free survival (PFS)
  time frame: Approximately 12 months
  description: Progression-free survival defined as the time elapsed between the date of commencement of treatment and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
  measure: Overall response rate (ORR)
  time frame: Approximately 12 months
  description: Overall response rate (ORR) was regarded as 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: Approximately 12 months
  description: Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate
  measure: Treatment-Related Adverse Events (TRAE)
  time frame: Approximately 12 months
  description: Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
  arm group label: Fruquintinib plus PD-1 inhibitors
  description: In fruquintinib plus PD-1 inhibitors group,The patients were treated orally with Fruquintinib (5mg once daily for 14 days on/7 days off, over a 21-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.
  arm group label: TAS-102 plus bevacizumab
  description: In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.
  intervention type: Drug
  intervention name: Fruquintinib
  description: 5mg once daily for 14 days on/7 days off, over a 21-day cycle
  arm group label: Fruquintinib plus PD-1 inhibitors
  intervention type: Drug
  intervention name: PD-1 inhibitors
  description: The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.
  arm group label: Fruquintinib plus PD-1 inhibitors
  other name: anti-PD-1 antibodies
  intervention type: Drug
  intervention name: Trifluridine/Tipiracil
  description: TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
  arm group label: TAS-102 plus bevacizumab
  other name: TAS-102
  other name: Lonsurf
  other name: S 95005
  intervention type: Drug
  intervention name: Bevacizumab
  description: Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days
  arm group label: TAS-102 plus bevacizumab
  other name: Avastin
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Rongrong li, professor
  role: Principal Investigator
  affiliation: Hunan Cancer Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Trifluridine
  mesh term: Bevacizumab
  mesh term: Immune Checkpoint Inhibitors
  sharing ipd: Yes
  ipd description: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for principal investigator or correspondence author]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: please contact the principal investigator of this study or correspondence author.