<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/NCT04440332</url>
  </required_header>
  <id_info>
    <org_study_id>3001</org_study_id>
    <nct_id>NCT04440332</nct_id>
  </id_info>
  <brief_title>Surveillance of Peripheral Blood of Lymphocyte and Immunocyte in Neoadjuvant Therapy Patients With Esophageal Squamous Cell Carcinoma (pLINE)</brief_title>
  <official_title>The Clinical Significance of Surveillance of Lymphocyte and Immunocyte Subsets in Peripheral Blood of Esophageal Squamous Cell Carcinoma Patients With Neoadjuvant Chemoradiotherapy Combine Surgery or Surgery Alone (pLINE）.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan Cancer Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sichuan Cancer Hospital and Research Institute</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>
      Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable&#xD;
      locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and&#xD;
      other perioperative complications were higher in patients who received esophagectomy and&#xD;
      neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients.&#xD;
      However, reliable clinical data can quantify the damage degree of immunologic function caused&#xD;
      by chemotherapy and radiotherapy is still unknown. This project regards the level of&#xD;
      lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic&#xD;
      change of the immunologic function of patients with locally advanced esophageal squamous cell&#xD;
      carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will&#xD;
      also investigate the relationship between the level of lymphocyte and immunocyte in&#xD;
      peripheral blood and the response rate of neoadjuvant therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral blood will be collected from patients who will undergo esophagectomy and/or&#xD;
      neoadjuvant therapy. The setting time is before chemoradiotherapy, finishing&#xD;
      chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood&#xD;
      samples will be used for detection and analysis in lymphocyte and immunocyte by flow&#xD;
      cytometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complete pathologic response rate and its relationship between peripheral blood of lymphocyte and immunocyte.</measure>
    <time_frame>3 months</time_frame>
    <description>Definition of complete pathologic response is &quot;no cancer cell, including lympho nodes&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pulmonary infection rate and its relationship between peripheral blood of lymphocyte and immunocyte.</measure>
    <time_frame>3 months</time_frame>
    <description>The pulmonary infection after surgery included bacterial pneumonia and viral pneumonia and fungal pneumonia.</description>
  </primary_outcome>
  <enrollment type="Anticipated">138</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <condition>Neoadjuvant Therapy</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with esophageal squamous cell carcinoma who accept esophagectomy alone or&#xD;
        neoadjuvant chemoradiotherapy treatment followed by surgery are acceptable.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Histologically confirmed locally advanced resectable thoracic ESCC; and requires&#xD;
             esophagectomy alone or neoadjuvant chemoradiotherapy combined surgery treatment;&#xD;
             Clinical stage T1-3N2-3M0 (AJCC 8 TNM classification);&#xD;
&#xD;
          -  2. At least one measurable lesion in accordance with RECIST 1.1;&#xD;
&#xD;
          -  3. Have a performance status of 0 or 1 on the ECOG Performance Scale;&#xD;
&#xD;
          -  4. Expected survival time is greater than 6 months;&#xD;
&#xD;
          -  5. Good organ function level: Hematology: white blood cell ≥3×10^9/L, neutrophil&#xD;
             ≥1.5×10^9/L, hemoglobin ≥90 g/L and platelet ≥100×10^9/L; hepatic function: total&#xD;
             bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), or total bilirubin&#xD;
             &gt; ULN, but direct bilirubin ≤ULN, ALT, AST ≤2.5 times the upper limit of normal value;&#xD;
             Renal function: serum creatinine ≤1.5 times of ULN; Coagulation function:&#xD;
             international normalized ratio (INR) or prothrombin time (PT) or activated partial&#xD;
             thromboplastin time (aPTT) ≤1.5 x ULN;&#xD;
&#xD;
          -  6. The electrocardiograph was generally normal, and the left ventricular ejection&#xD;
             fraction (LVEF) was ≥50%, Or the myocardial enzyme spectrum is in the normal range;&#xD;
&#xD;
          -  7. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) in the normal&#xD;
             range; If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and&#xD;
             FT4 in the normal range will also be enrolled;&#xD;
&#xD;
          -  8. Female subjects of childbearing potential have a negative pregnancy test and must&#xD;
             agree to take effective contraceptive measures during the study period and within 3&#xD;
             months after the last dose;&#xD;
&#xD;
          -  9. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients with possible tracheoesophageal fistula or aortic esophageal fistula;&#xD;
&#xD;
          -  2. Patients with active autoimmune disease or documented autoimmune disease or&#xD;
             symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;&#xD;
&#xD;
          -  3. Patients with immunodeficiency or who were still receiving systemic steroid hormone&#xD;
             therapy (prednisone &gt; 10 mg/ day or other equivalent drugs) or other forms of&#xD;
             immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in&#xD;
             this study;&#xD;
&#xD;
          -  4. Received anti-tumor therapy, including but not limited to chemotherapy,&#xD;
             radiotherapy, immunotherapy, and targeted therapy, within 28 days prior to initial&#xD;
             administration;&#xD;
&#xD;
          -  5. Patients with active infection who still required systemic treatment 7 days before&#xD;
             the first dose of neoadjuvant therapy in this study;&#xD;
&#xD;
          -  6. Uncontrolled brain metastases;&#xD;
&#xD;
          -  7. Patients with interstitial lung disease, non-infectious pneumonia, or pulmonary&#xD;
             fibrosis;&#xD;
&#xD;
          -  8. Patients with active tuberculosis (TB), who is receiving anti-TB treatment or who&#xD;
             has received anti-TB treatment within 1 year before the first drug use&#xD;
&#xD;
          -  9. Patients with uncontrolled diabetes (fasting blood glucose ≥CTCAE level 2);&#xD;
&#xD;
          -  10. Peripheral neuropathy of degree II or above was found within 4 weeks before&#xD;
             enrollment;&#xD;
&#xD;
          -  11.Patients who have received a foreign organ or stem cell transplant in the past;&#xD;
&#xD;
          -  12. Patients with allergies to the drugs or related ingredients in this study;&#xD;
&#xD;
          -  13. Patients with any serious or unstable medical condition or mental illness;&#xD;
&#xD;
          -  14. History of drug abuse or dependence;&#xD;
&#xD;
          -  15. Major organ disorders or diseases: liver and kidney dysfunction, history of&#xD;
             myocardial infarction, unstable heart disease, chronic active hepatitis, etc;&#xD;
&#xD;
          -  16. History of other malignancies within 5 years (except for cured cervical cancer or&#xD;
             basal cell carcinoma of the skin);&#xD;
&#xD;
          -  17. Patients who also participated in other clinical trials;&#xD;
&#xD;
          -  18. The researchers did not consider the patients suitable for any medical condition&#xD;
             under study.&#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_contact>
    <last_name>Xue-Feng Leng, M.D., Ph.D.</last_name>
    <phone>+86 18702870755</phone>
    <email>leng724@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital and Research Institute</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xue-Feng Leng, M.D., Ph.D.</last_name>
      <phone>+86 18702870755</phone>
      <email>leng724@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sichuan Cancer Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Yongtao Han</investigator_full_name>
    <investigator_title>Director,Head of Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>esophageal squamous cell carcinoma</keyword>
  <keyword>lymphocyte subsets</keyword>
  <keyword>neoadjuvant chemoradiotherapy</keyword>
  <keyword>immunocyte</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04440332
org study id: 3001
nct id: NCT04440332
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable
      locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and
      other perioperative complications were higher in patients who received esophagectomy and
      neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients.
      However, reliable clinical data can quantify the damage degree of immunologic function caused
      by chemotherapy and radiotherapy is still unknown. This project regards the level of
      lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic
      change of the immunologic function of patients with locally advanced esophageal squamous cell
      carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will
      also investigate the relationship between the level of lymphocyte and immunocyte in
      peripheral blood and the response rate of neoadjuvant therapy.
Peripheral blood will be collected from patients who will undergo esophagectomy and/or
      neoadjuvant therapy. The setting time is before chemoradiotherapy, finishing
      chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood
      samples will be used for detection and analysis in lymphocyte and immunocyte by flow
      cytometry.
observational model: Cohort
time perspective: Prospective
measure: Complete pathologic response rate and its relationship between peripheral blood of lymphocyte and immunocyte.
time frame: 3 months
description: Definition of complete pathologic response is "no cancer cell, including lympho nodes".
measure: Postoperative pulmonary infection rate and its relationship between peripheral blood of lymphocyte and immunocyte.
time frame: 3 months
description: The pulmonary infection after surgery included bacterial pneumonia and viral pneumonia and fungal pneumonia.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xue-Feng Leng, M.D., Ph.D.
phone: +86 18702870755
email: leng724@163.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sichuan Cancer Hospital and Research Institute
investigator full name: Yongtao Han
investigator title: Director,Head of Thoracic Surgery
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma