<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/NCT03792568</url>
  </required_header>
  <id_info>
    <org_study_id>AICAM</org_study_id>
    <nct_id>NCT03792568</nct_id>
  </id_info>
  <brief_title>ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.</brief_title>
  <official_title>ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Changzheng 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>
      This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic&#xD;
      Colorectal Cancer Patients with ALK mutation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <phase>N/A</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 Respone Rate(ORR)</measure>
    <time_frame>up to 36months</time_frame>
    <description>Evaluation of tumor burden based on RECIST criteria every 2 month.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>ALK mutation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ALK Inhibitor</intervention_name>
    <description>Any ALK inhibitor like crizotinib, alectinib and so on.</description>
    <arm_group_label>ALK mutation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients should be histologically diagnosed with metastatic colorectal cancer or&#xD;
        postoperative recurrence; Patients with ALK mutation(including mutation, fusion,&#xD;
        rearrangements ); Patients have measurable lesions; Patients are not available for targeted&#xD;
        therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3&#xD;
        weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be&#xD;
        18-25 years; Performance status should be 0-2; Life expectancy should be more than 12&#xD;
        weeks;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to&#xD;
        experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain&#xD;
        metastases; Patients with chemotherapy contraindication; Patients could not tolerate&#xD;
        chemotherapy; Patients have secondary primary tumor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan-sheng Zang, Prof.</last_name>
      <phone>+8613816584620</phone>
      <email>doctorzangys@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhan Wang, Prof.</last_name>
      <phone>+8613916229609</phone>
      <email>profoundamir@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei-ping Dai</last_name>
      <phone>+8618801790929</phone>
      <email>18801790929@139.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Zhan Wang</investigator_full_name>
    <investigator_title>ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation.</investigator_title>
  </responsible_party>
  <keyword>ALK mutation</keyword>
  <keyword>ALK inhibitor</keyword>
  <keyword>Metastatic Colorectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03792568
org study id: AICAM
nct id: NCT03792568
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic
      Colorectal Cancer Patients with ALK mutation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Respone Rate(ORR)
time frame: up to 36months
description: Evaluation of tumor burden based on RECIST criteria every 2 month.
arm group label: ALK mutation
arm group type: Experimental
intervention type: Other
intervention name: ALK Inhibitor
description: Any ALK inhibitor like crizotinib, alectinib and so on.
arm group label: ALK mutation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Zhan Wang
investigator title: ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation.
mesh term: Colorectal Neoplasms
sharing ipd: Yes