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/NCT05974059</url>
    </required_header>
    <id_info>
      <org_study_id>AK104-IIT-C-N1-0036</org_study_id>
      <nct_id>NCT05974059</nct_id>
    </id_info>
    <brief_title>Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer</brief_title>
    <official_title>Single-arm, Open-label, Single-center Phase II Clinical Study of Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Cancer Institute and Hospital</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>
        The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant&#xD;
        treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was a single arm, open-label, single-center clinical study to evaluate the&#xD;
        efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant&#xD;
        treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>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>Pathologic complete remission rate (PCR)</measure>
      <time_frame>up to 1 years</time_frame>
      <description>Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>3-year disease-free survival rate of 3year (DFS)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major pathological response rate (MPR)</measure>
      <time_frame>up to 1 years</time_frame>
      <description>Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to &lt; 10%, as determined by a pathologist</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate(ORR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events（AEs）</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Locally Advanced Unresectable Gastric Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Cadonilimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 mg/kg, d1, Q3W;</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxaliplatin</intervention_name>
      <description>Preoperative treatment：130mg/m2，iv, 2h，d1，Q3W; Postoperative treatment：130mg/m2，iv, 2h，d1，Q3W;</description>
      <arm_group_label>Cadonilimab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>Preoperative treatment：1000 mg /m2, PO，bid d1-14，Q3W； Postoperative treatment：1000 mg /m2, PO，bid. d1-14，Q3W；</description>
      <arm_group_label>Cadonilimab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cadonilimab</intervention_name>
      <description>Cadonilimab 10 mg/kg, d1, Q3W</description>
      <arm_group_label>Cadonilimab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female, 18 years ≤ age ≤ 75 years;&#xD;
  &#xD;
            2. ECOG score 0-1;&#xD;
  &#xD;
            3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the&#xD;
               gastroesophageal junction.&#xD;
  &#xD;
            4. c stageII, III(T1-4a/N+ M0, T3-4a/N-M0, AJCC 8th edition of gastric cancer cTNM stage)&#xD;
               were performed according to enhanced CT/MRI examination (combined with ultrasonic&#xD;
               gastroscopy and diagnostic laparoscopy if necessary).&#xD;
  &#xD;
            5. The study site and the operator can complete radical dissection of D2 lymph nodes (the&#xD;
               number of examined lymph nodes must be at least 15 to ensure the operation quality),&#xD;
               and R0 resection;&#xD;
  &#xD;
            6. Physical condition and organ function allow for larger abdominal surgery;&#xD;
  &#xD;
            7. It has adequate organ and bone marrow functions and is defined as follows:&#xD;
  &#xD;
          1)Blood routine test: absolute neutrophil count (ANC) ≥1.5×109/L; Platelet&#xD;
          count(PLT)≥100×109/L; Hemoglobin (HGB)≥9.0 g/dL; 2)Liver function: Total serum bilirubin&#xD;
          (TBIL) ≤1.5×upper limit of normal (ULN) is required for patients without liver metastasis.&#xD;
          alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5*ULN; 3)Renal&#xD;
          function: creatinine clearance rate (Ccr)≥50 mL/min (calculated by Cockcroft/Gault&#xD;
          formula); a Female: Ccr= (140-years) x Body Weight (kg) x 0.85 72 x serum creatinine&#xD;
          (mg/dL) b Males: Ccr= (140-years) x Weight (kg) x 1.00 72 x serum creatinine (mg/dL) 4)&#xD;
          Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time&#xD;
          (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT&#xD;
          is within the intended range of the anticoagulant; 8 Left ventricular ejection fraction&#xD;
          (LVEF)≥50% confirmed by echocardiography; 9 Agree and be able to comply with the protocol&#xD;
          during the study; 10 Provide written informed consent prior to entering study screening and&#xD;
          the patient is aware that she can withdraw from the study at any time during the study&#xD;
          without loss; 11 Consent to provide blood and histological specimens&#xD;
  &#xD;
          - Exclusion Criteria&#xD;
  &#xD;
            1. Complication of upper gastrointestinal tract obstruction/hemorrhage or digestive&#xD;
               dysfunction or malabsorption syndrome;&#xD;
  &#xD;
            2. Concomitant severe uncontrolled concurrent infection or other serious uncontrolled&#xD;
               concomitant disease, moderate or severe renal injury;&#xD;
  &#xD;
            3. Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or&#xD;
               immunotherapy;&#xD;
  &#xD;
            4. Other malignancies (except basal or squamous cell carcinoma, superficial bladder&#xD;
               cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;&#xD;
  &#xD;
            5. Uncontrolled pleural effusion, pericardial effusion or ascites;&#xD;
  &#xD;
            6. Serious cardiovascular disease such as symptomatic coronary heart disease, congestive&#xD;
               heart failure ≥Grade II, uncontrolled arrhythmia, myocardial infarction within 12&#xD;
               months prior to enrollment;&#xD;
  &#xD;
            7. Allergic reaction to the drugs used in this study;&#xD;
  &#xD;
            8. Use of steroids or other systemic immunosuppressive therapy 14 days prior to&#xD;
               enrollment;&#xD;
  &#xD;
            9. Patients receiving study medication within 4 weeks prior to enrollment (participating&#xD;
               in other clinical trials);&#xD;
  &#xD;
           10. Active autoimmune diseases;&#xD;
  &#xD;
           11. Medical history of primary immunodeficiency;&#xD;
  &#xD;
           12. Immunosuppressive medications were used within 4 weeks prior to the first dose of&#xD;
               study treatment, excluding nasal spray, inhaled or other local corticosteroids or&#xD;
               physiological doses of systemic corticosteroids (i.e. not more than 10 mg/day&#xD;
               prednisone or equivalent dose of other corticosteroids), or the use of hormones to&#xD;
               prevent contrast agent allergy;&#xD;
  &#xD;
           13. Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study&#xD;
               treatment or scheduled for the duration of the study;&#xD;
  &#xD;
           14. Known active tuberculosis;&#xD;
  &#xD;
           15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem&#xD;
               cell transplantation;&#xD;
  &#xD;
           16. HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV);&#xD;
  &#xD;
           17. Pregnant or lactating women;&#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>Xuewei Ding, MD</last_name>
      <role>Study Director</role>
      <affiliation>Tianjin Cancer Hospital Airport Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xuewei Ding, MD</last_name>
      <phone>18622220158</phone>
      <email>xding@tmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xuewei Ding</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300308</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xuewei Ding, MD</last_name>
        <phone>18622220158</phone>
        <email>xding@tmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 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 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Resectable locally advanced adenocarcinoma of the gastro-esophageal junction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Capecitabine</mesh_term>
      <mesh_term>Oxaliplatin</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/NCT05974059
  org study id: AK104-IIT-C-N1-0036
  nct id: NCT05974059
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant
        treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
  This study was a single arm, open-label, single-center clinical study to evaluate the
        efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant
        treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pathologic complete remission rate (PCR)
  time frame: up to 1 years
  description: Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
  measure: 3-year disease-free survival rate of 3year (DFS)
  time frame: up to 3 years
  description: 3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
  measure: Major pathological response rate (MPR)
  time frame: up to 1 years
  description: Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist
  measure: Objective response rate(ORR)
  time frame: up to 3 years
  description: Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
  measure: Disease Control Rate (DCR)
  time frame: up to 3 years
  description: Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD
  measure: Adverse Events（AEs）
  time frame: up to 3 years
  description: Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
  arm group label: Cadonilimab
  arm group type: Experimental
  description: 10 mg/kg, d1, Q3W;
  intervention type: Drug
  intervention name: Oxaliplatin
  description: Preoperative treatment：130mg/m2，iv, 2h，d1，Q3W; Postoperative treatment：130mg/m2，iv, 2h，d1，Q3W;
  arm group label: Cadonilimab
  intervention type: Drug
  intervention name: Capecitabine
  description: Preoperative treatment：1000 mg /m2, PO，bid d1-14，Q3W； Postoperative treatment：1000 mg /m2, PO，bid. d1-14，Q3W；
  arm group label: Cadonilimab
  intervention type: Drug
  intervention name: Cadonilimab
  description: Cadonilimab 10 mg/kg, d1, Q3W
  arm group label: Cadonilimab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xuewei Ding, MD
  role: Study Director
  affiliation: Tianjin Cancer Hospital Airport Hospital
  last name: Xuewei Ding, MD
  phone: 18622220158
  email: xding@tmu.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  sharing ipd: No