<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/NCT03807102</url>
  </required_header>
  <id_info>
    <org_study_id>TVATLC01</org_study_id>
    <nct_id>NCT03807102</nct_id>
  </id_info>
  <brief_title>Trail of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer</brief_title>
  <acronym>TVATLC01</acronym>
  <official_title>Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenxiang Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Houchao Biotechnology Co., Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hunan Province Tumor Hospital</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>
      Tumor vaccines may make the body build an immune response to kill tumor cells. This research&#xD;
      study is evaluating a new type of tumor vaccine termed as &quot;Neoantigen Tumor Vaccine&quot;. The&#xD;
      purpose of this phase I/II trial study is to assess the safety and effectiveness of&#xD;
      neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine&#xD;
      hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till&#xD;
      recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and&#xD;
      metastasis or unacceptable toxicity.&#xD;
&#xD;
      Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.&#xD;
&#xD;
      Projected accrual: A total of 30 patients will be accrued for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 16, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</primary_completion_date>
  <phase>Phase 1/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>Disease-free Survival (DFS)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>The time that participants stay free of cancer after surgery following administration of tumor vaccine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>30 days from first study vaccine administration</time_frame>
    <description>Number of participants experiencing clinical and laboratory adverse events</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Tumor Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of NeoAntigen Tumor Vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tumor Vaccine</intervention_name>
    <description>NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).</description>
    <arm_group_label>Tumor Vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 70 years, Male or Female&#xD;
&#xD;
          -  Histological or cytologically diagnosis of lung adenocarcinoma&#xD;
&#xD;
          -  After surgical treatment (lobectomy and systematic lymph node dissection)&#xD;
&#xD;
          -  Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition))&#xD;
&#xD;
          -  Postoperative standard treatment (platinum-based double-drug adjuvant treatment with&#xD;
             or without chemotherapy) or no adjuvant treatment&#xD;
&#xD;
          -  Have potential dynamic tumor biomarkers&#xD;
&#xD;
          -  Able and willing to give witnessed, written informed consent form prior to receiving&#xD;
             any study related procedure, agree to participate in long-term follow-up for up to 3&#xD;
             years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 or&lt; 70 years&#xD;
&#xD;
          -  Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer&#xD;
&#xD;
          -  Without surgical treatment&#xD;
&#xD;
          -  Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging&#xD;
             (eight Edition))&#xD;
&#xD;
          -  Participation in any other clinical trial involving another investigational agent&#xD;
             within 4 weeks prior to first dose of study vaccine&#xD;
&#xD;
          -  Drug or alcohol abusers&#xD;
&#xD;
          -  Pregnant or breast-feeding patients&#xD;
&#xD;
          -  History of immunodeficiency disease or autoimmune disease&#xD;
&#xD;
          -  Patients with chronic disease which is undergoing immune reagents or hormone therapy&#xD;
&#xD;
          -  Concurrent other medical condition that would prevent the patient from undergoing&#xD;
             protocol-based therapy&#xD;
&#xD;
          -  Lack of availability of a patient for immunological and clinical follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenxiang Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunan Provincal Tumor Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nong Yang, MD</last_name>
    <phone>+86 731 89762323</phone>
    <email>yangnong0217@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hunan Provincal Tumor Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
    <investigator_full_name>Wenxiang Wang</investigator_full_name>
    <investigator_title>MD, pHD, Director of Thoracic Surgery Department II</investigator_title>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_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/NCT03807102
org study id: TVATLC01
nct id: NCT03807102
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Tumor vaccines may make the body build an immune response to kill tumor cells. This research
      study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The
      purpose of this phase I/II trial study is to assess the safety and effectiveness of
      neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.
Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine
      hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till
      recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and
      metastasis or unacceptable toxicity.

      Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.

      Projected accrual: A total of 30 patients will be accrued for this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free Survival (DFS)
time frame: Approximately 2 years
description: The time that participants stay free of cancer after surgery following administration of tumor vaccine
measure: Adverse Events (AEs)
time frame: 30 days from first study vaccine administration
description: Number of participants experiencing clinical and laboratory adverse events
arm group label: Tumor Vaccine
arm group type: Experimental
description: Injection of NeoAntigen Tumor Vaccine
intervention type: Biological
intervention name: Tumor Vaccine
description: NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).
arm group label: Tumor Vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wenxiang Wang, MD, PhD
role: Principal Investigator
affiliation: Hunan Provincal Tumor Hospital
last name: Nong Yang, MD
phone: +86 731 89762323
email: yangnong0217@163.com
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hunan Province Tumor Hospital
investigator full name: Wenxiang Wang
investigator title: MD, pHD, Director of Thoracic Surgery Department II
mesh term: Lung Neoplasms
sharing ipd: No