<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/NCT03239015</url>
  </required_header>
  <id_info>
    <org_study_id>Long March Pathway</org_study_id>
    <nct_id>NCT03239015</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Precision Therapy in Refractory Tumor</brief_title>
  <official_title>Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baodong Qin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Changzheng 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>
      This study is intended to evaluate efficacy and safety of targeted precision therapy in&#xD;
      patients with refractory tumor, including rare tumor without standard recommended treatment&#xD;
      and common tumor after multiple line of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The individuals recruited in the present study are with solid tumor, mainly including two&#xD;
      parts: first, rare tumor without standard recommended treatment such as atypical fibrous&#xD;
      histiocytoma; second, common tumor after multiple line of therapy such as lung cancer,&#xD;
      gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on&#xD;
      NCCN guideline when recruiting. Next-generation sequence was used to detect druggable&#xD;
      molecular event including gene mutation, gene fusion, amplification, etc. Then patients with&#xD;
      molecular events were treated with corresponding targeted drug and followed-up, and not&#xD;
      limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without&#xD;
      durgguable targets. The efficacy and safety of these regimens were evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Objective Response Rate</measure>
    <time_frame>Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months</time_frame>
    <description>Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress Free Survival</measure>
    <time_frame>Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months</time_frame>
    <description>Time from treatment beginning until disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months</time_frame>
    <description>Time from treatment beginning until death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Effect</measure>
    <time_frame>Through study completion, an average of 1 months</time_frame>
    <description>Incidence of Treatment-related adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Rare Tumor</condition>
  <condition>Refractory Tumor</condition>
  <arm_group>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib</intervention_name>
    <description>Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <description>Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Afatinib</intervention_name>
    <description>Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxazolidine</intervention_name>
    <description>Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <description>Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vemurafenib</intervention_name>
    <description>Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabrafenib</intervention_name>
    <description>Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PD-1/L1 inhibitor plus anti-angiogenic agent</intervention_name>
    <description>PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target</description>
    <arm_group_label>Targeted Drug Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malignant solid tumors diagnosed histologically;&#xD;
&#xD;
          -  Common solid tumor patients have no any standard choice after multiple line of&#xD;
             therapy; Rare solid tumor did not have any standard recommended treatment;&#xD;
&#xD;
          -  Expected survival ≥ 1 month;&#xD;
&#xD;
          -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥&#xD;
             90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL &lt;1.5 times the upper limit of&#xD;
             normal (ULN); Liver ALT and AST &lt;2.5 × ULN and if liver metastases, ALT and AST &lt;5 ×&#xD;
             ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient still has standard treatment therapy based on NCCN guidance;&#xD;
&#xD;
          -  Patient can not comply with research program requirements or 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>
  <overall_official>
    <last_name>Yuan-Sheng Zang, MD.PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Changzheng Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao-dong Jiao, MD.PHD</last_name>
    <phone>+86-13817797639</phone>
    <email>pulava@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao-Dong Jiao, MD</last_name>
      <phone>+86-13817797639</phone>
      <email>pulava@139.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 16, 2022</last_update_submitted>
  <last_update_submitted_qc>February 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Baodong Qin</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Olaparib</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
    <mesh_term>Gefitinib</mesh_term>
    <mesh_term>Afatinib</mesh_term>
    <mesh_term>Vemurafenib</mesh_term>
    <mesh_term>Dabrafenib</mesh_term>
    <mesh_term>Angiogenesis Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03239015
org study id: Long March Pathway
nct id: NCT03239015
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is intended to evaluate efficacy and safety of targeted precision therapy in
      patients with refractory tumor, including rare tumor without standard recommended treatment
      and common tumor after multiple line of therapy.
The individuals recruited in the present study are with solid tumor, mainly including two
      parts: first, rare tumor without standard recommended treatment such as atypical fibrous
      histiocytoma; second, common tumor after multiple line of therapy such as lung cancer,
      gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on
      NCCN guideline when recruiting. Next-generation sequence was used to detect druggable
      molecular event including gene mutation, gene fusion, amplification, etc. Then patients with
      molecular events were treated with corresponding targeted drug and followed-up, and not
      limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without
      durgguable targets. The efficacy and safety of these regimens were evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
description: Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
measure: Progress Free Survival
time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
description: Time from treatment beginning until disease progression
measure: Overall Survival
time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
description: Time from treatment beginning until death from any cause
measure: Adverse Effect
time frame: Through study completion, an average of 1 months
description: Incidence of Treatment-related adverse Events
arm group label: Targeted Drug Therapy Group
arm group type: Experimental
description: All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
intervention type: Drug
intervention name: Gefitinib
description: Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Erlotinib
description: Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Afatinib
description: Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Trastuzumab
description: Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Oxazolidine
description: Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Olaparib
description: Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Everolimus
description: Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Cabozantinib
description: Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Vemurafenib
description: Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Dabrafenib
description: Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: Palbociclib
description: Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.
arm group label: Targeted Drug Therapy Group
intervention type: Drug
intervention name: PD-1/L1 inhibitor plus anti-angiogenic agent
description: PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target
arm group label: Targeted Drug Therapy Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yuan-Sheng Zang, MD.PHD
role: Principal Investigator
affiliation: Shanghai Changzheng Hospital
last name: Xiao-dong Jiao, MD.PHD
phone: +86-13817797639
email: pulava@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Baodong Qin
investigator title: Clinical Professor
mesh term: Neoplasms
mesh term: Trastuzumab
mesh term: Everolimus
mesh term: Olaparib
mesh term: Palbociclib
mesh term: Gefitinib
mesh term: Afatinib
mesh term: Vemurafenib
mesh term: Dabrafenib
mesh term: Angiogenesis Inhibitors
sharing ipd: No