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/NCT06038552</url>
    </required_header>
    <id_info>
      <org_study_id>No.[2023]352</org_study_id>
      <nct_id>NCT06038552</nct_id>
    </id_info>
    <brief_title>The Long-term Efficacy of Imatinib With Hepatic Resection or Other Local Treatment for GIST Liver Metastases</brief_title>
    <official_title>The Long-term Efficacy of Imatinib With Hepatic Resection or Other Local Treatment for Gastrointestinal Stromal Tumours Liver Metastases：a Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital, Sun Yat-Sen 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>
        The goal of this observational study is to evaluate the overall survival benefits of local&#xD;
        treatment combined with imatinib(IM) and IM alone in patients suffering from GIST liver&#xD;
        metastases. The main question it aims to answer is:&#xD;
  &#xD;
        • Whether IM combined with hepatic resection (HR) or other local treatments such as&#xD;
        radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) has better long-term&#xD;
        survival benefits compared to IM monotherapy.&#xD;
  &#xD;
        Patients are divided into different treatment groups:&#xD;
  &#xD;
          -  IM group&#xD;
  &#xD;
          -  IM combined with HR group&#xD;
  &#xD;
          -  IM combined with RFA or TACE group&#xD;
  &#xD;
        Researchers will compare the IM + HR group and IM + RFA/TACE group with the IM group to see&#xD;
        if it has a better Overall survival (OS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gastrointestinal stromal tumors (GISTs) represent the most prevalent type of mesenchymal&#xD;
        tumor within the gastrointestinal tract, and the liver is the most common site of metastasis&#xD;
        from GIST. Imatinib (IM) has significantly enhanced clinical outcomes for patients with&#xD;
        advanced disease. Since its approval in February 2002 for treating metastatic or unresectable&#xD;
        GISTs, 38% of patients have shown a partial response, while 13.6% have experienced disease&#xD;
        progression within 1 to 3 months of IM administration. Over half of the patients with&#xD;
        metastases experienced disease progression within two years of IM treatment, attributed to&#xD;
        secondary drug resistance. Few studies are comparing the survival benefits of different&#xD;
        surgical modalities. The investigators aimed to evaluate IM combined with hepatic resection&#xD;
        (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial&#xD;
        chemoembolization (TACE), compared to IM monotherapy in long-term survival benefits in&#xD;
        patients suffering from GIST liver metastases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2002</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 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</measure>
      <time_frame>up to 200 months</time_frame>
      <description>Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">238</enrollment>
    <condition>GIST, Malignant</condition>
    <condition>Liver Metastases</condition>
    <arm_group>
      <arm_group_label>IM group</arm_group_label>
      <description>Imatinib(IM)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IM combined with HR group</arm_group_label>
      <description>Imatinib(IM) combined with hepatic resection(HR)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IM combined with RFA or TACE group</arm_group_label>
      <description>Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>imatinib (IM)</intervention_name>
      <description>Patients with GIST liver metastases were administered an initial IM dose of 400 mg daily, while those with KIT exon 9 mutations received 600-800 mg daily. All patients continued IM indefinitely unless progression or intolerable adverse reactions.</description>
      <arm_group_label>IM combined with HR group</arm_group_label>
      <arm_group_label>IM combined with RFA or TACE group</arm_group_label>
      <arm_group_label>IM group</arm_group_label>
      <other_name>Gleevec</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>hepatic resection (HR)</intervention_name>
      <description>HR The determination of the surgical modality was established subsequent to comprehensive consultations tailored to each patient within the Department of Liver Surgery. The surgical strategy was established in consideration of factors such as the residual liver volume, tumour positioning, and the surgeon's personal preference. Employing an intraoperative ultrasonographic to enhance the precision of operative assessment.</description>
      <arm_group_label>IM combined with HR group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>radiofrequency ablation (RFA)</intervention_name>
      <description>RFA RFA was executed utilizing the commercially accessible Cool-tip™ RFA system or the RF 2000 system. The electrode was percutaneously inserted through a guide needle under real-time ultrasound guidance.The primary objective of the RFA procedures encompassed the complete elimination of the tumour entity, with a prescribed ablative margin of 0.5 cm meticulously factored in.</description>
      <arm_group_label>IM combined with RFA or TACE group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>transarterial chemoembolization (TACE)</intervention_name>
      <description>TACE Under a comprehensive assessment of the hepatic arterial blood supply, a selective catheter was introduced into the segmental or subsegmental arteries that supplied the tumour. The regimen of hepatic arterial infusion chemotherapy included infusion of carboplatin 300 mg, a mixture of 50 mg of epirubicin and 8 mg of mitomycin C, intimately blended with 5 mL of lipiodol. Embolization was finally performed with either absorbable gelatin sponge particles or polyvinyl alcohol particles .</description>
      <arm_group_label>IM combined with RFA or TACE group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          From January 2002 to April 2022, 330 consecutive patients were diagnosed with GIST liver&#xD;
          metastases. Finally, a total of 238 patients were enrolled in our study. The patients were&#xD;
          segregated into different treatment categories: IM therapy (n=126), IM combined with HR&#xD;
          (n=81) and IM combined with RFA/TACE (n=31).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathological evidence of GIST of primary tumors&#xD;
  &#xD;
            -  Liver metastases evidenced by biopsy or radiological findings&#xD;
  &#xD;
            -  Sufficient liver, hematologic, and renal function, coupled with an Eastern Cooperative&#xD;
               Oncology Group performance status score ranging from 0 to 1&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  IM was not used during treatment&#xD;
  &#xD;
            -  Liver metastases appeared on second-line or later subsequent lines of TKI&#xD;
  &#xD;
            -  Combined with other malignant tumors&#xD;
  &#xD;
            -  Failure to follow up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Xinhua Zhang, MD</investigator_full_name>
      <investigator_title>Deputy Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Imatinib Mesylate</mesh_term>
    </intervention_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/NCT06038552
  org study id: No.[2023]352
  nct id: NCT06038552
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate the overall survival benefits of local
        treatment combined with imatinib(IM) and IM alone in patients suffering from GIST liver
        metastases. The main question it aims to answer is:
  
        • Whether IM combined with hepatic resection (HR) or other local treatments such as
        radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) has better long-term
        survival benefits compared to IM monotherapy.
  
        Patients are divided into different treatment groups:
  
          -  IM group
  
          -  IM combined with HR group
  
          -  IM combined with RFA or TACE group
  
        Researchers will compare the IM + HR group and IM + RFA/TACE group with the IM group to see
        if it has a better Overall survival (OS).
  Gastrointestinal stromal tumors (GISTs) represent the most prevalent type of mesenchymal
        tumor within the gastrointestinal tract, and the liver is the most common site of metastasis
        from GIST. Imatinib (IM) has significantly enhanced clinical outcomes for patients with
        advanced disease. Since its approval in February 2002 for treating metastatic or unresectable
        GISTs, 38% of patients have shown a partial response, while 13.6% have experienced disease
        progression within 1 to 3 months of IM administration. Over half of the patients with
        metastases experienced disease progression within two years of IM treatment, attributed to
        secondary drug resistance. Few studies are comparing the survival benefits of different
        surgical modalities. The investigators aimed to evaluate IM combined with hepatic resection
        (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial
        chemoembolization (TACE), compared to IM monotherapy in long-term survival benefits in
        patients suffering from GIST liver metastases.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall survival
  time frame: up to 200 months
  description: Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.
  arm group label: IM group
  description: Imatinib(IM)
  arm group label: IM combined with HR group
  description: Imatinib(IM) combined with hepatic resection(HR)
  arm group label: IM combined with RFA or TACE group
  description: Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)
  intervention type: Drug
  intervention name: imatinib (IM)
  description: Patients with GIST liver metastases were administered an initial IM dose of 400 mg daily, while those with KIT exon 9 mutations received 600-800 mg daily. All patients continued IM indefinitely unless progression or intolerable adverse reactions.
  arm group label: IM combined with HR group
  arm group label: IM combined with RFA or TACE group
  arm group label: IM group
  other name: Gleevec
  intervention type: Procedure
  intervention name: hepatic resection (HR)
  description: HR The determination of the surgical modality was established subsequent to comprehensive consultations tailored to each patient within the Department of Liver Surgery. The surgical strategy was established in consideration of factors such as the residual liver volume, tumour positioning, and the surgeon's personal preference. Employing an intraoperative ultrasonographic to enhance the precision of operative assessment.
  arm group label: IM combined with HR group
  intervention type: Procedure
  intervention name: radiofrequency ablation (RFA)
  description: RFA RFA was executed utilizing the commercially accessible Cool-tip™ RFA system or the RF 2000 system. The electrode was percutaneously inserted through a guide needle under real-time ultrasound guidance.The primary objective of the RFA procedures encompassed the complete elimination of the tumour entity, with a prescribed ablative margin of 0.5 cm meticulously factored in.
  arm group label: IM combined with RFA or TACE group
  intervention type: Procedure
  intervention name: transarterial chemoembolization (TACE)
  description: TACE Under a comprehensive assessment of the hepatic arterial blood supply, a selective catheter was introduced into the segmental or subsegmental arteries that supplied the tumour. The regimen of hepatic arterial infusion chemotherapy included infusion of carboplatin 300 mg, a mixture of 50 mg of epirubicin and 8 mg of mitomycin C, intimately blended with 5 mL of lipiodol. Embolization was finally performed with either absorbable gelatin sponge particles or polyvinyl alcohol particles .
  arm group label: IM combined with RFA or TACE group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
  investigator full name: Xinhua Zhang, MD
  investigator title: Deputy Director
  mesh term: Neoplasm Metastasis
  mesh term: Liver Neoplasms
  mesh term: Imatinib Mesylate
  sharing ipd: No