<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/NCT04501887</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-ON-100</org_study_id>
    <nct_id>NCT04501887</nct_id>
  </id_info>
  <brief_title>The Efficacy of Precision Treatment for Gastric Cancer Guided by Molecular Profiling</brief_title>
  <official_title>The Efficacy of Precision Treatment for Gastric Cancer Guided by Multidimensional Molecular Biology Profiling: a Multi-center Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in&#xD;
      China, and the median overall survival for patients with advanced, metastatic GC remains only&#xD;
      about 1 year. Several molecular profiling studies have demonstrated that a proportion of&#xD;
      gastric cancer harbour actionable molecular alterations which shows a predictive benefit from&#xD;
      a specific therapy (in any cancer type). In the current study, the efficacy of precision&#xD;
      treatment for gastric cancer guided by multidimensional molecular biology profiling will be&#xD;
      observed. The analysis focused on the overall survival outcomes for patients whose tumours&#xD;
      harboured actionable molecular alterations and who received appropriately matched therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Overall survival was measured from the date of advanced disease until death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>The PFS was calculated from the date of advanced disease to the date of disease progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive rate</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Actionable molecular alterations detected by molecular profiling</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Matched therapy</arm_group_label>
    <description>Molecular profiling performed with actionable molecular alterations detected and target therapy was then conducted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unmatched therapy</arm_group_label>
    <description>Molecular profiling performed with actionable molecular alterations detected but therapy was conducted based on the guideline treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No marker</arm_group_label>
    <description>Molecular profiling performed without any actionable molecular alterations detected, tranditional therapy based on the guideline was then conducted</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with biopsy-confirmed gastric cancer at stage IV who conducted molecular testing&#xD;
        are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female. Age: 18-80 years.&#xD;
&#xD;
          2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction&#xD;
             with inoperable locally advanced or recurrent and/or metastatic disease, not amenable&#xD;
             to curative therapy.&#xD;
&#xD;
          3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).&#xD;
&#xD;
          4. Multidimensional molecular biology profiling has been conducted using tumor or blood&#xD;
             sample.&#xD;
&#xD;
          5. ECOG Performance status 0-1.&#xD;
&#xD;
          6. Life expectancy of at least 3 months.&#xD;
&#xD;
          7. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The quality of NGS reports does not fit the requirement.&#xD;
&#xD;
          2. History of documented congestive heart failure; angina pectoris requiring medication;&#xD;
             evidence of transmural myocardial infarction on ECG; poorly controlled hypertension&#xD;
             (systolic BP &gt; 180 mmHg or diastolic BP &gt; 100 mmHg); clinically significant valvular&#xD;
             heart disease; or high risk uncontrollable arrhythmias.&#xD;
&#xD;
          3. Baseline LVEF &lt; 50% (measured by echocardiography or MUGA).&#xD;
&#xD;
          4. Patients with dyspnea at rest due to complications of advanced malignancy or other&#xD;
             disease, or who require supportive oxygen therapy.&#xD;
&#xD;
          5. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and&#xD;
             short courses of oral steroids for anti-emesis or as an appetite stimulant are&#xD;
             allowed).&#xD;
&#xD;
          6. Known dihydropyrimidine dehydrogenase (DPD) deficiency.&#xD;
&#xD;
          7. History or clinical evidence of brain metastases.&#xD;
&#xD;
          8. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly&#xD;
             controlled diabetes.&#xD;
&#xD;
          9. Positive serum pregnancy test in women of childbearing potential.&#xD;
&#xD;
         10. Subjects with reproductive potential not willing to use an effective method of&#xD;
             contraception.&#xD;
&#xD;
         11. Major surgery within 4 weeks of start of study treatment, without complete recovery.&#xD;
&#xD;
         12. Patients with known active infection with HIV, HBV, or HCV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Tianshu Liu</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>precision medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT04501887
org study id: ZS-ON-100
nct id: NCT04501887
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in
      China, and the median overall survival for patients with advanced, metastatic GC remains only
      about 1 year. Several molecular profiling studies have demonstrated that a proportion of
      gastric cancer harbour actionable molecular alterations which shows a predictive benefit from
      a specific therapy (in any cancer type). In the current study, the efficacy of precision
      treatment for gastric cancer guided by multidimensional molecular biology profiling will be
      observed. The analysis focused on the overall survival outcomes for patients whose tumours
      harboured actionable molecular alterations and who received appropriately matched therapy.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: up to 3 years
description: Overall survival was measured from the date of advanced disease until death.
measure: Progression-free survival
time frame: up to 3 years
description: The PFS was calculated from the date of advanced disease to the date of disease progression or death
measure: Positive rate
time frame: up to 3 years
description: Actionable molecular alterations detected by molecular profiling
arm group label: Matched therapy
description: Molecular profiling performed with actionable molecular alterations detected and target therapy was then conducted
arm group label: Unmatched therapy
description: Molecular profiling performed with actionable molecular alterations detected but therapy was conducted based on the guideline treatment
arm group label: No marker
description: Molecular profiling performed without any actionable molecular alterations detected, tranditional therapy based on the guideline was then conducted
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Tianshu Liu
investigator title: Doctor
mesh term: Stomach Neoplasms