<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/NCT03269162</url>
  </required_header>
  <id_info>
    <org_study_id>SHDC12016114</org_study_id>
    <nct_id>NCT03269162</nct_id>
  </id_info>
  <brief_title>Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection</brief_title>
  <official_title>The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>lihegen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</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>
      Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing&#xD;
      relapse and metastasis of early postoperative NSCLC patients. Method: In this&#xD;
      multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with&#xD;
      complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with&#xD;
      chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group,&#xD;
      N=72). Peripheral blood CTCs and immune cells were detect on five different time points:&#xD;
      after operation、4 chemotherapy cycles were over、12 months after operation、18 months after&#xD;
      operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined&#xD;
      with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life&#xD;
      of postoperative patients; and decreasing the side effect of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 30, 2016</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Disease-free survival Rate</measure>
    <time_frame>2 years</time_frame>
    <description>From the very beginning of the randomization to the end point when disease relapse or death because of any reason</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>Jinfukang + Chemotherapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jinfukang Koufuye</intervention_name>
    <description>30ml per time, tid, po (d6-21, q21)</description>
    <arm_group_label>Jinfukang + Chemotherapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>75mg/m2,ivgtt 30mins, d1</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Jinfukang + Chemotherapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>500mg/m2, ivgtt 30mins, d1</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Jinfukang + Chemotherapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>75mg/m2, ivgtt &gt;2h, d1</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Jinfukang + Chemotherapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage&#xD;
             IB-IIB&#xD;
&#xD;
          2. Accept chemotherapy for the first time 6 weeks after operation&#xD;
&#xD;
          3. Age of 18-75 years old&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group-PS≤2&#xD;
&#xD;
          5. N&gt;1.5×109/L、PLT&gt; 100 × 109/L、Hb&gt;100g/dL、Liver and kidney function is normal or&#xD;
             elevated ≤ 1.5 times&#xD;
&#xD;
          6. Voluntary participation in the prospective study with signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No pathology-confirmed diagnosis patients&#xD;
&#xD;
          2. Patients with overall survival time&lt;6 months&#xD;
&#xD;
          3. Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the&#xD;
             same time&#xD;
&#xD;
          4. Pregnant or breast feeding patients&#xD;
&#xD;
          5. Patients with uncontrollable mentally disease&#xD;
&#xD;
          6. Patients with diabetes&#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>Hegen Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Longhua Hospital</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>lihegen</investigator_full_name>
    <investigator_title>Director of Oncology Department Longhua Hospital</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 26, 2021</submitted>
    <submission_canceled>February 26, 2021</submission_canceled>
  </pending_results>
  <!-- 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/NCT03269162
org study id: SHDC12016114
nct id: NCT03269162
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing
      relapse and metastasis of early postoperative NSCLC patients. Method: In this
      multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with
      complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with
      chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group,
      N=72). Peripheral blood CTCs and immune cells were detect on five different time points:
      after operation、4 chemotherapy cycles were over、12 months after operation、18 months after
      operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined
      with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life
      of postoperative patients; and decreasing the side effect of chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival Rate
time frame: 2 years
description: From the very beginning of the randomization to the end point when disease relapse or death because of any reason
arm group label: Jinfukang + Chemotherapy Group
arm group type: Experimental
arm group label: Chemotherapy Group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Jinfukang Koufuye
description: 30ml per time, tid, po (d6-21, q21)
arm group label: Jinfukang + Chemotherapy Group
intervention type: Drug
intervention name: Docetaxel
description: 75mg/m2,ivgtt 30mins, d1
arm group label: Chemotherapy Group
arm group label: Jinfukang + Chemotherapy Group
intervention type: Drug
intervention name: Pemetrexed
description: 500mg/m2, ivgtt 30mins, d1
arm group label: Chemotherapy Group
arm group label: Jinfukang + Chemotherapy Group
intervention type: Drug
intervention name: Cisplatin
description: 75mg/m2, ivgtt >2h, d1
arm group label: Chemotherapy Group
arm group label: Jinfukang + Chemotherapy Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hegen Li
role: Principal Investigator
affiliation: Longhua Hospital
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai University of Traditional Chinese Medicine
investigator full name: lihegen
investigator title: Director of Oncology Department Longhua Hospital
mesh term: Docetaxel
mesh term: Pemetrexed
submitted: February 26, 2021
submission canceled: February 26, 2021