<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/NCT03772132</url>
  </required_header>
  <id_info>
    <org_study_id>DLY20181206</org_study_id>
    <nct_id>NCT03772132</nct_id>
  </id_info>
  <brief_title>Chemothetapy 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>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 FORFIRINOX&#xD;
      in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX&#xD;
      in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment, consistent with RECIST version 1.1 criteria for solid tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients with Clinical Benefit Response</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.&#xD;
Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cholangiocarcinoma of the Extrahepatic Bile Duct</condition>
  <condition>Gallbladder Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</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>mutation and signal pathway activation status analysis Drug: FORFIRINOX</intervention_name>
    <description>Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • 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,&#xD;
                  who are not suitable for radical surgery or have progressed R1 resection or&#xD;
                  palliative surgery;&#xD;
&#xD;
               -  Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry&#xD;
                  test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine&#xD;
                  kinase signal pathway components;&#xD;
&#xD;
               -  At least one measurable and evaluable site of disease according to the RECIST&#xD;
                  criteria 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&#xD;
                  (ULN), 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&#xD;
                  pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received following treatment before this study:&#xD;
&#xD;
               1. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;&#xD;
&#xD;
               2. lesions have been treated by irradiation;&#xD;
&#xD;
               3. participate in other therapeutic or interventional clinical trials. - Page 5 of 5&#xD;
                  [DRAFT] -&#xD;
&#xD;
          -  Have central nervous system metastasis;&#xD;
&#xD;
          -  History of other malignancies except carcinoma in-situ of uterine cervix, cured basal&#xD;
             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 moderate or&#xD;
                  serious hypertension(systolic blood pressure &gt;21.3 Kpa or diastolic blood&#xD;
                  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 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</last_name>
      <phone>13918803900</phone>
      <email>laoniulyb@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, 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/NCT03772132
org study id: DLY20181206
nct id: NCT03772132
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX
      in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX
      in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
allocation: N/A
intervention model: Single Group 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.
measure: Overall survival
time frame: up to 2 years
measure: Objective Response Rate
time frame: up to 1 year
description: Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment, consistent with RECIST version 1.1 criteria for solid tumors.
measure: Disease Control Rate
time frame: up to 1 year
description: Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors.
measure: percentage of patients with Clinical Benefit Response
time frame: up to 1 year
description: Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.
Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
arm group label: Chemotherapy
arm group type: Experimental
description: The patients wil receive conventional chemotherapy FORFIRINOX
intervention type: Biological
intervention name: mutation and signal pathway activation status analysis Drug: FORFIRINOX
description: Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy
arm group label: Chemotherapy
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: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, 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