<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/NCT04431791</url>
  </required_header>
  <id_info>
    <org_study_id>Reg vs Fru</org_study_id>
    <nct_id>NCT04431791</nct_id>
  </id_info>
  <brief_title>Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer</brief_title>
  <official_title>A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      This is an observational, ambispective cohort study. The aim is to compare the efficacy and&#xD;
      safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic&#xD;
      colorectal cancer patients after second-line therapy will be assigned to receive either&#xD;
      regorafenib or fruquintinib, based on decision of the gastrointestinal physician according&#xD;
      the patients' condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time To Treatment Failure</measure>
    <time_frame>every month, up to discontinuation of treatment for any reason.</time_frame>
    <description>the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>from enrollment of the first subject until the database cut-off approximately 6 months later.</time_frame>
    <description>the time from first dose to the death for any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>from enrollment of the first subject until the database cut-off approximately 6 months later.</time_frame>
    <description>the time from first dose to disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events（AEs）</measure>
    <time_frame>from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.</time_frame>
    <description>percentage of patients with AEs according to CTCAE 4.03</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">268</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Regorafenib</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Fruquintinib</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Regorafenib</intervention_name>
    <description>oral regorafenib</description>
    <arm_group_label>Regorafenib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fruquintinib</intervention_name>
    <description>oral fruquintinib</description>
    <arm_group_label>Fruquintinib</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with signing the informed consent, would be enrolled when their gastrointestinal&#xD;
        physician prescribed to receive regorafenib or fruquintinib after second-line according the&#xD;
        condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. signed and dated informed consent.&#xD;
&#xD;
          2. Diagnosis of histologically confirmed colorectal cancer, stage IV.&#xD;
&#xD;
          3. after second-line therapy.&#xD;
&#xD;
          4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according&#xD;
             the patients' condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. received regorafenib or fruquintinib before third-line therapy.&#xD;
&#xD;
          2. the clinicopathological characteristics and previous therapy were unknown.&#xD;
&#xD;
          3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Li, MD</last_name>
      <phone>86-010-88196088</phone>
      <email>oncogene@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>Targeted therapy</keyword>
  <keyword>TTF</keyword>
  <keyword>OS</keyword>
  <keyword>PFS</keyword>
  <keyword>AE</keyword>
  <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>


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/NCT04431791
org study id: Reg vs Fru
nct id: NCT04431791
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an observational, ambispective cohort study. The aim is to compare the efficacy and
      safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic
      colorectal cancer patients after second-line therapy will be assigned to receive either
      regorafenib or fruquintinib, based on decision of the gastrointestinal physician according
      the patients' condition.
observational model: Cohort
time perspective: Other
measure: Time To Treatment Failure
time frame: every month, up to discontinuation of treatment for any reason.
description: the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
measure: Overall survival
time frame: from enrollment of the first subject until the database cut-off approximately 6 months later.
description: the time from first dose to the death for any cause.
measure: Progression-free survival
time frame: from enrollment of the first subject until the database cut-off approximately 6 months later.
description: the time from first dose to disease progression.
measure: Incidence of adverse events（AEs）
time frame: from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
description: percentage of patients with AEs according to CTCAE 4.03
arm group label: Regorafenib
arm group label: Fruquintinib
intervention type: Drug
intervention name: Regorafenib
description: oral regorafenib
arm group label: Regorafenib
intervention type: Drug
intervention name: Fruquintinib
description: oral fruquintinib
arm group label: Fruquintinib
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
mesh term: Colorectal Neoplasms