<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/NCT03751592</url>
  </required_header>
  <id_info>
    <org_study_id>LYS-LC-01</org_study_id>
    <nct_id>NCT03751592</nct_id>
  </id_info>
  <brief_title>Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer</brief_title>
  <official_title>A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</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 Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous&#xD;
      non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development&#xD;
      on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of&#xD;
      phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced&#xD;
           Lung Cancer Patients;&#xD;
&#xD;
        2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung&#xD;
           Cancer Patients;&#xD;
&#xD;
        3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the&#xD;
           advanced Lung Cancer Patients;&#xD;
&#xD;
        4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the&#xD;
           advanced Lung Cancer Patients;&#xD;
&#xD;
        5. Determine Eastern Cooperative Oncology Group（ECOG）.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 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 control rate（DCR)</measure>
    <time_frame>Within the first 10 weeks after the first dose of chlorogenic acid for injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>objective response rate (ORR)</measure>
    <time_frame>Within the first 10 weeks after the first dose of chlorogenic acid for injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progress free survival(PFS)</measure>
    <time_frame>Within the first 10 weeks after the first dose of chlorogenic acid for injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival（OS）</measure>
    <time_frame>Within the first 10 weeks after the first dose of chlorogenic acid for injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eastern Cooperative Oncology Group （ECOG） score standard</measure>
    <time_frame>Within the first 10 weeks after the first dose of chlorogenic acid for injection</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Advanced Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Chlorogenic acid, Treatment, powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorogenic acid</intervention_name>
    <description>Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.</description>
    <arm_group_label>Chlorogenic acid, Treatment, powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18;&#xD;
&#xD;
          2. Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC)&#xD;
             and adeniform NSCLC;&#xD;
&#xD;
          3. Estimated lifetime ≥ 3 months；&#xD;
&#xD;
          4. Patients who have sufficient baseline organ function and whose laboratory data can&#xD;
             meet the following criteria at the enrollment:1)PLT count≥80×10~9/L； 2)NEUT#&#xD;
             count≥1.5×10~9/L ；3)HGB count≥90g/L；4)Total bilirubin &lt;=1.5 times of ULN；5)ALT/AST&#xD;
             ≤2.5 times of ULN；&#xD;
&#xD;
          5. Female patients with negative pregnant test, and male/female patients of reproductive&#xD;
             age without pregnancy planning in the next 12 months;&#xD;
&#xD;
          6. Volunteered for the phase 1 trial and sign the informed consent without protest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who suffer from other serious complication, such as uncontrollable infection,&#xD;
             myocardial infarction within the past 6 months at the enrollment , uncontrollable&#xD;
             hypertension ,thromboembolism and etc.;&#xD;
&#xD;
          2. Patients with brain metastases;&#xD;
&#xD;
          3. Patients with bone metastases;&#xD;
&#xD;
          4. Patients who have primary immunodeficiency;&#xD;
&#xD;
          5. Organ transplanters recipients;&#xD;
&#xD;
          6. Patients who have received the therapy of chemotherapy within 4 weeks or radical&#xD;
             radiotherapy with in 6 weeks before enrollment;&#xD;
&#xD;
          7. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy&#xD;
             plan;&#xD;
&#xD;
          8. Patients who had received a therapy of another investigational drug within 1 month；&#xD;
&#xD;
          9. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;&#xD;
&#xD;
         10. Patients who have received therapy of major surgery within 6 weeks or biopsy surgery&#xD;
             within 2 weeks before enrollment;&#xD;
&#xD;
         11. Patient who need long term treatment of cortical hormone or other immunosuppressive&#xD;
             drugs such as visceral organ transplanters；&#xD;
&#xD;
         12. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine&#xD;
             kinase inhibitor within 2 weeks before enrollment;&#xD;
&#xD;
         13. Patients who or have received radical radiotherapy within 6 weeks or local palliative&#xD;
             radiotherapy within 2 weeks before enrollment;&#xD;
&#xD;
         14. History of drug abuse；&#xD;
&#xD;
         15. Patients who was treated with Immunologic drugs in 3 months;&#xD;
&#xD;
         16. Other patients judged ineligible for enrollment in the study by the investigator&#xD;
             (sub-investigator).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuankai Shi, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheng Yang, Dr</last_name>
    <phone>8613683260156</phone>
    <email>medart@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jianping Xu, Dr</last_name>
    <phone>8613651379626</phone>
    <email>13651379626@139.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yuankai Shi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03751592
org study id: LYS-LC-01
nct id: NCT03751592
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous
      non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development
      on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of
      phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.
1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced
           Lung Cancer Patients;

        2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung
           Cancer Patients;

        3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the
           advanced Lung Cancer Patients;

        4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the
           advanced Lung Cancer Patients;

        5. Determine Eastern Cooperative Oncology Group（ECOG）.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: disease control rate（DCR)
time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: objective response rate (ORR)
time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: progress free survival(PFS)
time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: Overall Survival（OS）
time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: Eastern Cooperative Oncology Group （ECOG） score standard
time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
arm group label: Chlorogenic acid, Treatment, powder
arm group type: Experimental
description: Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
intervention type: Drug
intervention name: Chlorogenic acid
description: Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
arm group label: Chlorogenic acid, Treatment, powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuankai Shi, Dr
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Sheng Yang, Dr
phone: 8613683260156
email: medart@126.com
last name: Jianping Xu, Dr
phone: 8613651379626
email: 13651379626@139.com
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No