<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/NCT03783559</url>
  </required_header>
  <id_info>
    <org_study_id>TACECRLM</org_study_id>
    <nct_id>NCT03783559</nct_id>
  </id_info>
  <brief_title>TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)</brief_title>
  <official_title>TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      To date no randomized controlled trials have been completed that demonstrated whether&#xD;
      TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy&#xD;
      (target therapy) with respect to advantages in conversion resection rates and survival&#xD;
      compared with chemotherapy (target therapy) alone for patients who failed with first-line&#xD;
      chemotherapy.The primary objective of this trial is to determine conversion resection rates&#xD;
      and survival for patients with colorectal cancer liver metastasis are treated with TACE plus&#xD;
      chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd&#xD;
      line.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>conversion resection rates</measure>
    <time_frame>2-4months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Colorectal Adenocarcinoma Metastatic to the Liver</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TACE plus chemotherapy ± target therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>chemotherapy ± target therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TACE</intervention_name>
    <description>TACE</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy±target therapy</intervention_name>
    <description>chemotherapy±target therapy</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed CRLM&#xD;
&#xD;
          -  disease limited to the liver Unresectable disease by surgery or other local therapies&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B&#xD;
&#xD;
          -  Expected survival ≥ 3 months&#xD;
&#xD;
          -  Adequate hematological, hepatic and renal function&#xD;
&#xD;
          -  PD(progressive disease) after first line chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  patients with severe organ dysfunction or failure&#xD;
&#xD;
          -  with severe cardiovascular or mental disease&#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>Jianmin Xu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of General Surgery, Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xu jianmin</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>colorectal cancer liver metastasis</keyword>
  <keyword>Transarterial chemoembolization</keyword>
  <keyword>conversion resection rates</keyword>
  <keyword>chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</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/NCT03783559
org study id: TACECRLM
nct id: NCT03783559
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To date no randomized controlled trials have been completed that demonstrated whether
      TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy
      (target therapy) with respect to advantages in conversion resection rates and survival
      compared with chemotherapy (target therapy) alone for patients who failed with first-line
      chemotherapy.The primary objective of this trial is to determine conversion resection rates
      and survival for patients with colorectal cancer liver metastasis are treated with TACE plus
      chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd
      line.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 6 months
measure: overall survival
time frame: 6 months
measure: conversion resection rates
time frame: 2-4months
arm group label: Arm A
arm group type: Experimental
description: TACE plus chemotherapy ± target therapy
arm group label: Arm B
arm group type: Active Comparator
description: chemotherapy ± target therapy
intervention type: Drug
intervention name: TACE
description: TACE
arm group label: Arm A
intervention type: Drug
intervention name: chemotherapy±target therapy
description: chemotherapy±target therapy
arm group label: Arm A
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianmin Xu, PhD
role: Study Chair
affiliation: Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xu jianmin
investigator title: Prof.
mesh term: Adenocarcinoma