xml: <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/NCT06006650</url>
    </required_header>
    <id_info>
      <org_study_id>K202208-28</org_study_id>
      <nct_id>NCT06006650</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell</brief_title>
    <official_title>Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tang-Du 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>
        The aim of this study was to investigate the efficacy and safety of pembrolizumab combined&#xD;
        with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or&#xD;
        5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal&#xD;
        squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly&#xD;
        assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy&#xD;
        (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and&#xD;
        cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks&#xD;
        later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed&#xD;
        up for efficacy and safety during treatment.Tumor evaluation will be performed at screening,&#xD;
        after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease&#xD;
        progression is confirmed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study was to investigate the efficacy and safety of pembrolizumab combined&#xD;
        with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or&#xD;
        5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal&#xD;
        squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly&#xD;
        assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy&#xD;
        (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and&#xD;
        cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks&#xD;
        later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed&#xD;
        up for efficacy and safety during treatment.Tumor evaluation will be performed at screening,&#xD;
        after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease&#xD;
        progression is confirmed.&#xD;
  &#xD;
        Study Endpoints Primary Endpoints PCR: This was assessed by examining the postoperative&#xD;
        pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes.&#xD;
  &#xD;
        Safety: Adverse reactions during neoadjuvant therapy were recorded following CTCAE version&#xD;
        5.0 guidelines. Perioperative complications were assessed using the Clavien-Dindo&#xD;
        classification. Grade I complications included any deviation from the normal postoperative&#xD;
        recovery process without requiring medical, surgical, endoscopic, or radiological&#xD;
        intervention. Acceptable medical management included antiemetics, antipyretics, analgesics,&#xD;
        diuretics, electrolytes, and physical therapy. Bedside open incisional infections were&#xD;
        included under this category. Grade II complications were those that required medications&#xD;
        beyond those used for treating Grade 1 complications, including blood transfusions and total&#xD;
        parenteral nutrition. Grade III complications were those that required surgical, endoscopic,&#xD;
        or radiological intervention. Grade IV complications were those considered life-threatening&#xD;
        and requiring mid-term care or admission to an intensive care unit (including central nervous&#xD;
        system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid&#xD;
        hemorrhage, and excluding transient ischemic attacks). Grade V complications included patient&#xD;
        deaths.&#xD;
  &#xD;
        Secondary Endpoints&#xD;
  &#xD;
        1) Major pathological response (MPR) refers to the proportion of residual tumor cells in the&#xD;
        primary tumor and lymph nodes in the postoperative pathological tissue being &lt;10%, or the&#xD;
        primary tumor completely disappearing, and the number of positive lymph nodes being ≤1. 2) R0&#xD;
        resection rate: R0 resection was defined as achieving negative upper and lower resection&#xD;
        margins. 3) RECIST Criteria Assessment: Complete response (CR): complete response of target&#xD;
        lesions; PR: &gt;30% regression of target lesions; Non-CR/Non-PD: target lesions did not&#xD;
        completely disappear and did not increase by &gt;20%, or other new lesions appeared in the body;&#xD;
        Stable disease (SD): target lesions were reduced or increased by &lt;20%; Progressive disease&#xD;
        (PD): target lesions had increased by &gt;20%.&#xD;
  &#xD;
        Statistical Methods The sample size was determined using Simon's two-stage design. With a&#xD;
        minimum expected pCR of 20% and an expected pCR of 40%, a Type I error (α) of 0.05, and a&#xD;
        Type II error of 80%, a sample size of 34 was calculated. In the first stage, 17 patients&#xD;
        were enrolled. The study was carefully monitored to limit the number of pCR cases to three or&#xD;
        below, and any increase in the risk of surgery and mortality due to the treatment regimen&#xD;
        would have led to its discontinuation. All continuous variables were presented as&#xD;
        frequencies. Statistical significance was set at P &lt;0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2031</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2031</primary_completion_date>
    <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pathologic complete response rate (pCR)</measure>
      <time_frame>up to 4 months</time_frame>
      <description>Pathologic complete response rate (pCR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major pathological response(MPR)</measure>
      <time_frame>up to 4 months</time_frame>
      <description>Major pathological response(MPR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event free survival(EFS)</measure>
      <time_frame>up to 10 years</time_frame>
      <description>Event free survival(EFS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival(OS)</measure>
      <time_frame>up to 10 years</time_frame>
      <description>Overall survival(OS)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Neoadjuvent</condition>
    <condition>PD-1 Inhibitor</condition>
    <condition>Chemotherapy</condition>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Pembrolizumab Plus Albumin Paclitaxel and Cisplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ albumin paclitaxel 100mg/m2, d1/d8/d15 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pembrolizumab Plus 5-fluorouracil and Cisplatin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ 5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>5-fluorouracil and Cisplatin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Preoperative neoadjuvant (5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin</intervention_name>
      <description>Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin</description>
      <arm_group_label>5-fluorouracil and Cisplatin</arm_group_label>
      <arm_group_label>Pembrolizumab Plus 5-fluorouracil and Cisplatin</arm_group_label>
      <arm_group_label>Pembrolizumab Plus Albumin Paclitaxel and Cisplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical&#xD;
          stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy;&#xD;
          5.ECOG PS score 0-1. 6.Organs function well:Hemoglobin ≥100g/L, white blood cell count&#xD;
          ≥4*10^9/L or neutrophil count ≥2.5*10^9/L, platelet count ≥100*10^9/L, serum total&#xD;
          bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5&#xD;
          times the upper limit of normal,Alanine aminotransferase (ALT) ≤2.5 times the upper limit&#xD;
          of normal, serum creatinine level below the upper limit of normal or creatinine clearance&#xD;
          rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein &lt;+, if urinary protein +, 24-hour&#xD;
          total protein must be &lt;500mg, blood glucose:In patients with normal-range and/or diabetes&#xD;
          under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least&#xD;
          2L;If the baseline FEV1 was &lt;2L, the predicted FEV1 after surgery was &gt;800ml, and the&#xD;
          cardiac function was: no myocardial infarction within 1 year;Unstable angina&#xD;
          pectoris;Asymptomatic severe arrhythmias;The centerless function is incomplete;&#xD;
          7.Non-surgically sterilized women, or women of reproductive age, need to use a medically&#xD;
          approved contraceptive method (such as an intrauterine device, birth control pill, or&#xD;
          condom) during and for 3 months after the end of the study treatment period.Women of&#xD;
          childbearing age who were not surgically sterilized had to have a negative serum or urine&#xD;
          HCG test within 72 hours before study enrollment.And must be non-lactation period;For male&#xD;
          patients with partners of women of childbearing age, effective methods of contraception&#xD;
          should be used during the trial period and within 3 months after the last dose of&#xD;
          treatment; 8.Sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pathological findings suggest compound squamous cell carcinoma, including squamous&#xD;
               adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.&#xD;
  &#xD;
            2. History of subtotal gastrectomy;&#xD;
  &#xD;
            3. accompanied by a second primary cancer;&#xD;
  &#xD;
            4. Tumor metabolic imaging prior to treatment suggested distant metastasis.&#xD;
  &#xD;
            5. people who have previously received chemoradiotherapy;&#xD;
  &#xD;
            6. preesophageal perforation signs&#xD;
  &#xD;
            7. pregnant women of reproductive age;&#xD;
  &#xD;
            8. Any active autoimmune disease or a history of autoimmune disease (such as autoimmune&#xD;
               hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis,&#xD;
               myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);&#xD;
  &#xD;
            9. People with the following active infectious diseases, including active tuberculosis,&#xD;
               hepatitis, and known human immunodeficiency virus (HIV) infection;&#xD;
  &#xD;
           10. Someone who has a known or concomitant hemorrhagic disease or other uncontrollable&#xD;
               disease that cannot be treated surgically;&#xD;
  &#xD;
           11. Physical examination or clinical trial findings that researchers believe could&#xD;
               interfere with the outcome or put the patient at increased risk of treatment&#xD;
               complications;&#xD;
  &#xD;
           12. A previous history of interstitial lung disease, drug-induced interstitial disease,&#xD;
               radiation pneumonitis requiring hormone therapy, or any clinically documented active&#xD;
               interstitial lung disease, and the presence of idiopathic pulmonary fibrosis on CT&#xD;
               scan at baseline;Uncontrolled massive pleural or pericardial effusion;&#xD;
  &#xD;
           13. unstable systemic diseases (active infection, moderately severe chronic obstructive&#xD;
               pulmonary disease (copd), poorly controlled hypertension, unstable angina and&#xD;
               congestive heart failure, 6 months occurrence of myocardial infarction, drug control&#xD;
               severe mental disorders, liver, kidney or other metabolic disease, nerve mental&#xD;
               disease such as Alzheimer 's disease);&#xD;
  &#xD;
           14. Gastrointestinal dysfunction, malabsorption syndrome, active gastrointestinal ulcers;&#xD;
  &#xD;
           15. Previously treated with anti-PD-1 or anti-PD-L1 antibodies;&#xD;
  &#xD;
           16. Receiving any investigational drug within 4 weeks before the first use of the&#xD;
               investigational drug;&#xD;
  &#xD;
           17. Enroll in another clinical study at the same time, unless it's an observational&#xD;
               (non-intervention) clinical study or an intervention clinical study follow-up;&#xD;
  &#xD;
           18. Subjects who require systematic treatment with corticosteroids (equivalent dose of&#xD;
               prednisone &gt; 10 mg per day) or other immunosuppressive agents within 2 weeks prior to&#xD;
               the first use of the study drug, except for the use of corticosteroids for local&#xD;
               esophageal inflammation and prevention of allergy, nausea, and vomiting.Other special&#xD;
               circumstances, need to communicate with the sponsor.In the absence of active&#xD;
               autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement&#xD;
               at doses &gt; 10mg/ day in response to prednisone are permitted;&#xD;
  &#xD;
           19. People who have been vaccinated with anti-tumor vaccine or who have been vaccinated&#xD;
               with live vaccine within 4 weeks prior to the first administration of the study drug;&#xD;
  &#xD;
           20. Major surgery or severe trauma within 4 weeks before the first use of the study drug;&#xD;
  &#xD;
           21. Congenital or acquired immunodeficiency disease or a history of organ&#xD;
               transplantation;A history of allergies to monoclonal antibodies, albumin paclitaxel,&#xD;
               5-fluorouracil, cisplatin, and other platinum-based drugs&#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>Xiaolong Yan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tang-Du Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaolong Yan, MD</last_name>
      <phone>029-847171569</phone>
      <email>yanxiaolong@fmmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>HongTao Duan, MD</last_name>
      <phone>029-847171569</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tangdu Hospital of the Fourth Millitary Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710038</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaolong Yan, MD</last_name>
        <phone>+862984717558</phone>
        <email>yanxiaolong@fmmu.edu.cn</email>
      </contact>
      <investigator>
        <last_name>Xiaolong Yan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tao Jiang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hongtao Duan</name>
        <address>
          <city>Xi'an</city>
          <state>Shanxi</state>
          <zip>710038</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongtao Duan, MD</last_name>
        <email>646014852@qq.com</email>
      </contact>
      <investigator>
        <last_name>Xiaolong Yan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tao Jiang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tangdu Hospital, the Air Force Military University</name>
        <address>
          <city>Xi'an</city>
          <zip>710038</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaolong Yan, Dr.</last_name>
        <phone>029-847171569</phone>
        <email>yanxiaolong@fmmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tang-Du Hospital</investigator_affiliation>
      <investigator_full_name>yanxiaolong</investigator_full_name>
      <investigator_title>Department of Thoracic Surgery at Tangdu Hospital, Air Force Medical University</investigator_title>
    </responsible_party>
    <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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
      <mesh_term>Fluorouracil</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006650
  org study id: K202208-28
  nct id: NCT06006650
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to investigate the efficacy and safety of pembrolizumab combined
        with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or
        5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal
        squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly
        assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy
        (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and
        cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks
        later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed
        up for efficacy and safety during treatment.Tumor evaluation will be performed at screening,
        after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease
        progression is confirmed.
  The aim of this study was to investigate the efficacy and safety of pembrolizumab combined
        with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or
        5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal
        squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly
        assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy
        (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and
        cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks
        later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed
        up for efficacy and safety during treatment.Tumor evaluation will be performed at screening,
        after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease
        progression is confirmed.
  
        Study Endpoints Primary Endpoints PCR: This was assessed by examining the postoperative
        pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes.
  
        Safety: Adverse reactions during neoadjuvant therapy were recorded following CTCAE version
        5.0 guidelines. Perioperative complications were assessed using the Clavien-Dindo
        classification. Grade I complications included any deviation from the normal postoperative
        recovery process without requiring medical, surgical, endoscopic, or radiological
        intervention. Acceptable medical management included antiemetics, antipyretics, analgesics,
        diuretics, electrolytes, and physical therapy. Bedside open incisional infections were
        included under this category. Grade II complications were those that required medications
        beyond those used for treating Grade 1 complications, including blood transfusions and total
        parenteral nutrition. Grade III complications were those that required surgical, endoscopic,
        or radiological intervention. Grade IV complications were those considered life-threatening
        and requiring mid-term care or admission to an intensive care unit (including central nervous
        system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid
        hemorrhage, and excluding transient ischemic attacks). Grade V complications included patient
        deaths.
  
        Secondary Endpoints
  
        1) Major pathological response (MPR) refers to the proportion of residual tumor cells in the
        primary tumor and lymph nodes in the postoperative pathological tissue being <10%, or the
        primary tumor completely disappearing, and the number of positive lymph nodes being ≤1. 2) R0
        resection rate: R0 resection was defined as achieving negative upper and lower resection
        margins. 3) RECIST Criteria Assessment: Complete response (CR): complete response of target
        lesions; PR: >30% regression of target lesions; Non-CR/Non-PD: target lesions did not
        completely disappear and did not increase by >20%, or other new lesions appeared in the body;
        Stable disease (SD): target lesions were reduced or increased by <20%; Progressive disease
        (PD): target lesions had increased by >20%.
  
        Statistical Methods The sample size was determined using Simon's two-stage design. With a
        minimum expected pCR of 20% and an expected pCR of 40%, a Type I error (α) of 0.05, and a
        Type II error of 80%, a sample size of 34 was calculated. In the first stage, 17 patients
        were enrolled. The study was carefully monitored to limit the number of pCR cases to three or
        below, and any increase in the risk of surgery and mortality due to the treatment regimen
        would have led to its discontinuation. All continuous variables were presented as
        frequencies. Statistical significance was set at P <0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Pathologic complete response rate (pCR)
  time frame: up to 4 months
  description: Pathologic complete response rate (pCR)
  measure: Major pathological response(MPR)
  time frame: up to 4 months
  description: Major pathological response(MPR)
  measure: Event free survival(EFS)
  time frame: up to 10 years
  description: Event free survival(EFS)
  measure: Overall survival(OS)
  time frame: up to 10 years
  description: Overall survival(OS)
  arm group label: Pembrolizumab Plus Albumin Paclitaxel and Cisplatin
  arm group type: Experimental
  description: Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ albumin paclitaxel 100mg/m2, d1/d8/d15 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy
  arm group label: Pembrolizumab Plus 5-fluorouracil and Cisplatin
  arm group type: Active Comparator
  description: Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ 5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy
  arm group label: 5-fluorouracil and Cisplatin
  arm group type: Active Comparator
  description: Preoperative neoadjuvant (5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy
  intervention type: Drug
  intervention name: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
  description: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
  arm group label: 5-fluorouracil and Cisplatin
  arm group label: Pembrolizumab Plus 5-fluorouracil and Cisplatin
  arm group label: Pembrolizumab Plus Albumin Paclitaxel and Cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xiaolong Yan, MD
  role: Principal Investigator
  affiliation: Tang-Du Hospital
  last name: Xiaolong Yan, MD
  phone: 029-847171569
  email: yanxiaolong@fmmu.edu.cn
  last name: HongTao Duan, MD
  phone: 029-847171569
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tang-Du Hospital
  investigator full name: yanxiaolong
  investigator title: Department of Thoracic Surgery at Tangdu Hospital, Air Force Medical University
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Paclitaxel
  mesh term: Pembrolizumab
  mesh term: Fluorouracil
  sharing ipd: No