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/NCT06027775</url>
    </required_header>
    <id_info>
      <org_study_id>CAPTIUM</org_study_id>
      <nct_id>NCT06027775</nct_id>
    </id_info>
    <brief_title>Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases</brief_title>
    <official_title>Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: A Retrospective Cohort Study</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>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce&#xD;
        the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM&#xD;
        patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can&#xD;
        benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with&#xD;
        a tolerable toxicity profile.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This multi-center study enrolled consecutive patients with initially unresectable CRLM who&#xD;
        underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status&#xD;
        between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan&#xD;
        Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1)&#xD;
        with histologically confirmed CRC; (2) with initially unresectable synchronous liver&#xD;
        metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable&#xD;
        status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The&#xD;
        exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3)&#xD;
        accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant&#xD;
        therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort&#xD;
        and CT cohort. The study was approved by the ethics committee of three medical centers and&#xD;
        was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written&#xD;
        informed consent was obtained from all participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2013</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>relapse-free survival</measure>
      <time_frame>3 years</time_frame>
      <description>The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>overall survival</measure>
      <time_frame>5 years</time_frame>
      <description>The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">198</enrollment>
    <condition>Colorectal Cancer Metastatic</condition>
    <arm_group>
      <arm_group_label>Chemotherapy plus Targeted therapy (CT)</arm_group_label>
      <description>The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chemotherapy Alone (CA)</arm_group_label>
      <description>In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy, as adjuvant therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Targeted agent</intervention_name>
      <description>The two cohorts received different adjuvant therapy regimens, with the CT group receiving chemotherapy plus targeted therapy; the CA group received chemotherapy alone.</description>
      <arm_group_label>Chemotherapy plus Targeted therapy (CT)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Initially unresectable CRLM patients who were successfully converted and achieved no&#xD;
          evidence of disease status from June 2013 to June 2020 were retrospectively collected. 1:2&#xD;
          propensity score matching (PSM) was performed to balance the baseline characteristics&#xD;
          between CA and CT cohorts. After PSM, 196 patients werethe disease-free survival (DFS) and&#xD;
          overall survival (OS) were evaluated between two cohorts （CA:N=66, CT:N=132）.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 and ≤ 75 years;&#xD;
  &#xD;
            2. Histologically confirmed CRC;&#xD;
  &#xD;
            3. Initially unresectable synchronous liver metastases (LMs);&#xD;
  &#xD;
            4. Accepted conversion therapy and successfully converted into resectable status;&#xD;
  &#xD;
            5. Underwent R0 intestinal and hepatic resection;&#xD;
  &#xD;
            6. Accepted adjuvant therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. R1/R2 resection;&#xD;
  &#xD;
            2. Extrahepatic metastases;&#xD;
  &#xD;
            3. Accepted postoperative monotherapy;&#xD;
  &#xD;
            4. Lack of follow-up data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jianmin Xu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Head of Colorectal Surgery</investigator_title>
    </responsible_party>
    <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>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/NCT06027775
  org study id: CAPTIUM
  nct id: NCT06027775
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce
        the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM
        patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can
        benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with
        a tolerable toxicity profile.
  This multi-center study enrolled consecutive patients with initially unresectable CRLM who
        underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status
        between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan
        Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1)
        with histologically confirmed CRC; (2) with initially unresectable synchronous liver
        metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable
        status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The
        exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3)
        accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant
        therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort
        and CT cohort. The study was approved by the ethics committee of three medical centers and
        was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written
        informed consent was obtained from all participants.
  observational model: Cohort
  time perspective: Retrospective
  measure: relapse-free survival
  time frame: 3 years
  description: The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death
  measure: overall survival
  time frame: 5 years
  description: The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.
  arm group label: Chemotherapy plus Targeted therapy (CT)
  description: The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy.
  arm group label: Chemotherapy Alone (CA)
  description: In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy, as adjuvant therapy.
  intervention type: Drug
  intervention name: Targeted agent
  description: The two cohorts received different adjuvant therapy regimens, with the CT group receiving chemotherapy plus targeted therapy; the CA group received chemotherapy alone.
  arm group label: Chemotherapy plus Targeted therapy (CT)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Jianmin Xu, MD
  role: Principal Investigator
  affiliation: Fudan University
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Xu jianmin
  investigator title: Head of Colorectal Surgery
  mesh term: Colorectal Neoplasms
  sharing ipd: No