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/NCT05984342</url>
    </required_header>
    <id_info>
      <org_study_id>2023045</org_study_id>
      <nct_id>NCT05984342</nct_id>
    </id_info>
    <brief_title>Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma</brief_title>
    <official_title>Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Affiliated Cancer Hospital of Shantou University Medical College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Affiliated Cancer Hospital of Shantou University Medical College</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>
        Esophageal cancer is one of the most common malignancies in China, and esophageal squamous&#xD;
        cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a&#xD;
        standard therapeutic approach for patients with resectable ESCC, but the prognosis is still&#xD;
        disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended&#xD;
        for patients with locally advanced ESCC, it is still an infrequently used procedure in China.&#xD;
        The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577&#xD;
        trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual&#xD;
        disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative&#xD;
        adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed&#xD;
        a prospective randomized controlled tial to study whether immunotherapy could be used with&#xD;
        chemotherapy after surgery to improve overall survival in these patients. The primary&#xD;
        endpoint of the study is disease free survival, with secondary endpoints of overall survival,&#xD;
        safety and toxicity, and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>Phase 1</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 rate</measure>
      <time_frame>1 years after surgery</time_frame>
      <description>disease free survival after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of adverse events</measure>
      <time_frame>within 6 months</time_frame>
      <description>Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Adjuvant Chemotherapy in Combination With Immunotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)</description>
      <arm_group_label>Adjuvant Chemotherapy in Combination With Immunotherapy</arm_group_label>
      <other_name>nab-paclitaxel</other_name>
      <other_name>Cisplatin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged between 18 and 70 years&#xD;
  &#xD;
            2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and&#xD;
               immunotherapy)&#xD;
  &#xD;
            3. Histologically documented squamous cell carcinoma of the thoracic esophagus with&#xD;
               positive lymph nodes （T1-3N1-3M0）&#xD;
  &#xD;
            4. undergoing radical esophagectomy&#xD;
  &#xD;
            5. ECOG (Eastern Cooperative Oncology Group) : 0-1&#xD;
  &#xD;
            6. No recurrent disease before adjuvant therapy&#xD;
  &#xD;
            7. Normal hemodynamic indices before the recruitment&#xD;
  &#xD;
            8. Able to understand this study and have signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. previous or concurrent malignancy&#xD;
  &#xD;
            2. Interstitial lung disease&#xD;
  &#xD;
            3. Requiring systemic treatment with either corticosteroids or other immunosuppressive&#xD;
               medications&#xD;
  &#xD;
            4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab&#xD;
  &#xD;
            5. Active autoimmune disease&#xD;
  &#xD;
            6. Active hepatitis&#xD;
  &#xD;
            7. Those whom the investigator considered unsuitable for inclusion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Cancer Hospital of Shantou University Medical College</name>
        <address>
          <city>Shantou</city>
          <state>Guangdong</state>
          <zip>515031</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shao-bin Chen</last_name>
        <phone>+8613417000759</phone>
        <email>chensb535176@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Affiliated Cancer Hospital of Shantou University Medical College</investigator_affiliation>
      <investigator_full_name>Shao-bin Chen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>esophageal squamous cell carcinoma</keyword>
    <keyword>immunotherapy</keyword>
    <keyword>chemotherapy</keyword>
    <keyword>surgery</keyword>
    <keyword>adjuvant therapy</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Cisplatin</mesh_term>
      <mesh_term>Tislelizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05984342
  org study id: 2023045
  nct id: NCT05984342
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Esophageal cancer is one of the most common malignancies in China, and esophageal squamous
        cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a
        standard therapeutic approach for patients with resectable ESCC, but the prognosis is still
        disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended
        for patients with locally advanced ESCC, it is still an infrequently used procedure in China.
        The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577
        trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual
        disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative
        adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed
        a prospective randomized controlled tial to study whether immunotherapy could be used with
        chemotherapy after surgery to improve overall survival in these patients. The primary
        endpoint of the study is disease free survival, with secondary endpoints of overall survival,
        safety and toxicity, and quality of life.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: disease-free survival rate
  time frame: 1 years after surgery
  description: disease free survival after surgery
  measure: Rate of adverse events
  time frame: within 6 months
  description: Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)
  arm group label: Adjuvant Chemotherapy in Combination With Immunotherapy
  arm group type: Experimental
  description: Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery
  intervention type: Drug
  intervention name: Tislelizumab
  description: Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)
  arm group label: Adjuvant Chemotherapy in Combination With Immunotherapy
  other name: nab-paclitaxel
  other name: Cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Affiliated Cancer Hospital of Shantou University Medical College
  investigator full name: Shao-bin Chen
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Paclitaxel
  mesh term: Cisplatin
  mesh term: Tislelizumab
  sharing ipd: Undecided