<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/NCT03768375</url>
  </required_header>
  <id_info>
    <org_study_id>DLY201812</org_study_id>
    <nct_id>NCT03768375</nct_id>
  </id_info>
  <brief_title>Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma</brief_title>
  <official_title>A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eastern Hepatobiliary Surgery Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the feasibility, efficacy and safety of target&#xD;
      therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or&#xD;
      recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic&#xD;
      changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status&#xD;
      of signal pathways involved in study.These information will be used to recommend target&#xD;
      therapy which may be more likely to result in a beneficial response.Patients will receive&#xD;
      target anti-tumor agents according to the result of genomic and proteomic profiling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 2</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>up to 1 year</time_frame>
    <description>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cholangiocarcinoma of the Extrahepatic Bile Duct</condition>
  <condition>Gallbladder Cancer</condition>
  <arm_group>
    <arm_group_label>target therap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients wil receive conventional chemotherapy(FORFIRINOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FORFIRINOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients wil receive conventional chemotherapy(FORFIRINOX)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>conventional chemotherapy(FORFIRINOX) combined with target agents</intervention_name>
    <description>Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib</description>
    <arm_group_label>target therap</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>conventional chemotherapy(FORFIRINOX)</intervention_name>
    <description>conventional chemotherapy(FORFIRINOX)</description>
    <arm_group_label>FORFIRINOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:• Chinese；&#xD;
&#xD;
          -  Stable vital signs, KPS≥60;&#xD;
&#xD;
          -  Patients have a diagnosis of advanced or recurrent metastatic extrahepatic&#xD;
             cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who&#xD;
             are not suitable for radical surgery or have progressed R1 resection or palliative&#xD;
             surgery;&#xD;
&#xD;
          -  Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry test;&#xD;
             harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal&#xD;
             pathway components;&#xD;
&#xD;
          -  At least one measurable and evaluable site of disease according to the RECIST criteria&#xD;
             version 1.1;&#xD;
&#xD;
          -  Life expectancy of more than 12 weeks;&#xD;
&#xD;
          -  Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN),&#xD;
             AST≤10×ULN, the Child-Pugh classification for class A or B, white blood&#xD;
             cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥80×10^9/L , hemoglobin ≥ 90g/L,&#xD;
             creatinine clearance rate≥60ml/min;&#xD;
&#xD;
          -  Volunteer for this study, have written informed consent and have good Patient&#xD;
             compliance;&#xD;
&#xD;
          -  Female patients of childbearing potential and their mates agree to avoid pregnancy.&#xD;
&#xD;
        Exclusion Criteria:• Have received following treatment before this study:&#xD;
&#xD;
        a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions&#xD;
        have been treated by irradiation; c. participate in other therapeutic or interventional&#xD;
        clinical trials.&#xD;
&#xD;
          -  Have central nervous system metastasis;&#xD;
&#xD;
               -  History of other malignancies except carcinoma in-situ of uterine cervix, cured&#xD;
                  basal cell carcinoma of skin and other malignancies for more than 5 years;&#xD;
&#xD;
               -  Have symptomatic ascites and need for treatment;&#xD;
&#xD;
               -  Have serious concurrent illness including, but not limited to&#xD;
&#xD;
                    1. uncontrolled congestive heart failure(NYHA classification grade III or IV),&#xD;
                       unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled&#xD;
                       moderate or serious hypertension(systolic blood pressure &gt;21.3 Kpa or&#xD;
                       diastolic blood pressure &gt;13.3 Kpa);&#xD;
&#xD;
                    2. ongoing or active serious infection;&#xD;
&#xD;
                    3. uncontrolled diabetes mellitus;&#xD;
&#xD;
                    4. psychiatric illness which potentially hamper the ability to willingly give&#xD;
                       written informed consent and compliance with the study protocol;&#xD;
&#xD;
                    5. HIV infection;&#xD;
&#xD;
                    6. other serious illness considered not suitable for this study by&#xD;
                       investigators.&#xD;
&#xD;
               -  be allergic or have contraindications to target medicines involved in this study,&#xD;
                  gemcitabine or oxaliplatin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yingbin liu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yingbin liu, PHD</last_name>
    <phone>+86 13918803900</phone>
    <email>laoniulyb@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingbin Liu, PHD</last_name>
      <phone>13918803900</phone>
      <email>laoniulyb@163.com</email>
    </contact>
    <investigator>
      <last_name>yingbin liu, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>liu yingbin</investigator_full_name>
    <investigator_title>head of general surgery department，xin hua Hospital Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Gallbladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03768375
org study id: DLY201812
nct id: NCT03768375
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to evaluate the feasibility, efficacy and safety of target
      therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or
      recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic
      changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status
      of signal pathways involved in study.These information will be used to recommend target
      therapy which may be more likely to result in a beneficial response.Patients will receive
      target anti-tumor agents according to the result of genomic and proteomic profiling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: up to 1 year
description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.
arm group label: target therap
arm group type: Experimental
description: The patients wil receive conventional chemotherapy(FORFIRINOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
arm group label: FORFIRINOX
arm group type: Experimental
description: The patients wil receive conventional chemotherapy(FORFIRINOX)
intervention type: Biological
intervention name: conventional chemotherapy(FORFIRINOX) combined with target agents
description: Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib
arm group label: target therap
intervention type: Biological
intervention name: conventional chemotherapy(FORFIRINOX)
description: conventional chemotherapy(FORFIRINOX)
arm group label: FORFIRINOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: yingbin liu, PHD
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
last name: yingbin liu, PHD
phone: +86 13918803900
email: laoniulyb@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: liu yingbin
investigator title: head of general surgery department，xin hua Hospital Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
mesh term: Cholangiocarcinoma
mesh term: Gallbladder Neoplasms
sharing ipd: Undecided