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/NCT05994456</url>
    </required_header>
    <id_info>
      <org_study_id>HP001</org_study_id>
      <nct_id>NCT05994456</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer</brief_title>
    <official_title>Neoadjuvant Toripalimab in the Treatment of Locally Advanced dMMR/MSI-H Gastric or Gastroesophageal Junction Adenocarcinoma：an Open-label, Single-arm，Multi-center，Phase II Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</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>
        This is a single-center, open phase II clinical trial to evaluate the tolerability, safety&#xD;
        and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric&#xD;
        or gastroesophageal junction adenocarcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip,&#xD;
        Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab&#xD;
        treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from&#xD;
        study according to their anti-tumor efficacy. For patients withdrawing from study, routine&#xD;
        treatment would be given. For patients staying in study, toripalimab would be administered&#xD;
        for up to 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 9, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Pathological complete remission (pCR) rates</measure>
      <time_frame>12 weeks</time_frame>
      <description>Percentage of patients who achieve pathological complete remission (pCR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>R0 resection rates</measure>
      <time_frame>12 weeks</time_frame>
      <description>The proportion of patients experiencing a R0 resection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>three-year disease-free survival rate, DFS</measure>
      <time_frame>3 years</time_frame>
      <description>Percentage of patients who achieve disease-free survival lasting for more than three years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>three-year Overall survival rate,OS</measure>
      <time_frame>3 years</time_frame>
      <description>Percentage of patients who achieve survival for more than two years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment-Related Adverse Events</measure>
      <time_frame>3 years</time_frame>
      <description>Number of adverse events.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Gastric or Gastroesophageal Junction Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>PD-1 inhibitor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neoadjuvant therapy with PD-1 inhibitor (Toripalimab)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PD-1 inhibitor</intervention_name>
      <description>240mg, Q3W. The opportunity for surgery was evaluated after 2 cycles of treatment and surgical treatment was performed after 2-4 cycles of treatment. Postoperatively, adjuvant therapy was continued according to the neoadjuvant regimen, and direct treatment met the criteria for termination of treatment.</description>
      <arm_group_label>PD-1 inhibitor</arm_group_label>
      <other_name>Toripalimab</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Aged 18-75 years, regardless of gender 2. Patients with histologically or cytologically&#xD;
          confirmed adenocarcinoma of the stomach or gastroesophageal junction and confirmed dMMR or&#xD;
          MSI-H 3. Preoperative CT or MRI staging meeting the following criteria: T2 and above, with&#xD;
          or without lymph node involvement, without clear distant metastasis 4. ECOG score of 0-1.&#xD;
          5. Expected survival ≥ 2 years. 6. Good organ function (no blood transfusion, no&#xD;
          hematopoietic stimulating factor, no albumin or blood product transfusion within 14 days&#xD;
          prior to the examination).&#xD;
  &#xD;
            1. Platelet (PLT) count ≥ 90*109/L.&#xD;
  &#xD;
            2. Neutrophil count (ANC) ≥ 1.5*109/L.&#xD;
  &#xD;
            3. Hemoglobin (Hb) level ≥ 9.0 g/dl.&#xD;
  &#xD;
            4. International normalized ratio (INR) ≤ 1.5.&#xD;
  &#xD;
            5. Prothrombin time (PT) and active partial thromboplastin time (APTT) ≤ 1.5 x ULN.&#xD;
  &#xD;
            6. Glycated hemoglobin (HbA1c) &lt;7.5%.&#xD;
  &#xD;
            7. Total bilirubin (TBIL) level ≤ 1.5 times the upper limit of normal (ULN).&#xD;
  &#xD;
            8. Alanine amino transaminase (ALT) and aspartate amino transaminase (AST) levels ≤ 2.5 x&#xD;
               ULN.&#xD;
  &#xD;
            9. Serum creatinine (Cr) level ≤ 1.5 x ULN and creatinine clearance ≥ 60 ml/min.&#xD;
  &#xD;
           10. Thyrotropin (TSH) ≤ ULN; serum free thyroid hormone (T4) normal; serum free&#xD;
               triiodothyronine (T3) normal; (except for those who have received previous thyroid&#xD;
               surgery or have a history of head and neck radiotherapy)&#xD;
  &#xD;
           11. Serum amylase ≤ 1.5 x ULN.&#xD;
  &#xD;
           12. Lipase ≤ 1.5×ULN. 7. Women of childbearing age must have a negative pregnancy test and&#xD;
               must use contraception and avoid breastfeeding during the study and for 3 months after&#xD;
               the last dose; male subjects must agree to use contraception during the study and for&#xD;
               3 months after the last dose.&#xD;
  &#xD;
          8.Be able to understand and willing to sign a written informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previously received chemotherapy, radiotherapy or immunotherapy for gastric cancer&#xD;
  &#xD;
            2. Previously diagnosed any other malignancy with a primary site or histological type&#xD;
               different from gastric cancer within 5 years prior to study entry, except adequately&#xD;
               treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix&#xD;
  &#xD;
            3. With known hypersensitivity to the study drug or excipients, or to similar drugs&#xD;
  &#xD;
            4. Received major surgery or open biopsy, or had a major trauma within 4 weeks prior to&#xD;
               the start of study treatment&#xD;
  &#xD;
            5. Received immunosuppressive drugs (excluding inhaled corticosteroids or ≤10 mg/day&#xD;
               prednisone or equivalent pharmacophysiologic doses of other systemic steroids) within&#xD;
               2 weeks prior to the start of study treatment&#xD;
  &#xD;
            6. Planned live attenuated vaccination within 4 weeks prior to the start of study&#xD;
               treatment or during the study period&#xD;
  &#xD;
            7. Inability to discontinue CYP3A4 inducers or inhibitors within 1 week prior to the&#xD;
               start of study treatment and during the study period&#xD;
  &#xD;
            8. Presence of any autoimmune disease or history of autoimmune disease.&#xD;
  &#xD;
            9. Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active&#xD;
               hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus&#xD;
               (HBV) infection (HBsAg positive and HBV-DNA ≥ 2000 IU/ml copies/ml)), or other serious&#xD;
               infection requiring antibiotics for systemic therapy, or during screening/study&#xD;
               Unexplained temperature &gt;38.5°C prior to the start of treatment.&#xD;
  &#xD;
           10. Presence of the following diseases within 6 months prior to the start of study&#xD;
               treatment: myocardial infarction, severe/unstable angina, NYHA class 2 or higher&#xD;
               congestive heart failure, poorly controlled arrhythmias, etc.&#xD;
  &#xD;
           11. Non-well-controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic&#xD;
               blood pressure ≥ 100 mmHg under optimal treatment)&#xD;
  &#xD;
           12. Arterial/venous thrombotic events such as cerebrovascular accidents (transient&#xD;
               ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep vein&#xD;
               thrombosis, vasculitis, etc. within 3 months prior to the start of study treatment&#xD;
  &#xD;
           13. Urine routine suggesting urine protein up to +++ and confirmed 24-hour urine protein&#xD;
               quantification up to 1.0g.&#xD;
  &#xD;
           14. The presence of a history of allogeneic organ transplantation or allogeneic&#xD;
               hematopoietic stem cell transplantation&#xD;
  &#xD;
           15. Seizures requiring medication (e.g., steroids or antiepileptic drugs) for treatment.&#xD;
  &#xD;
           16. Presence of a history of substance abuse, drug use, or alcohol dependence. Patients&#xD;
               with other serious, acute or chronic medical conditions that may increase the risk of&#xD;
               study participation and study medication, or that may interfere with the&#xD;
               interpretation of study results, and who are judged by the investigator to be&#xD;
               unsuitable for participation in a clinical trial.&#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>Dongsheng Zhang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dongsheng Zhang, PhD</last_name>
      <phone>86-2087343795</phone>
      <email>zhangdsh@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dongsheng Zhang, Dr.</last_name>
        <phone>+8602087343560</phone>
        <email>zhangds@sysucc.org.cn</email>
      </contact>
      <investigator>
        <last_name>Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Dong sheng Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>dMMR/MSI-H</keyword>
    <keyword>Gastric cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05994456
  org study id: HP001
  nct id: NCT05994456
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, open phase II clinical trial to evaluate the tolerability, safety
        and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric
        or gastroesophageal junction adenocarcinoma.
  In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip,
        Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab
        treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from
        study according to their anti-tumor efficacy. For patients withdrawing from study, routine
        treatment would be given. For patients staying in study, toripalimab would be administered
        for up to 2 years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pathological complete remission (pCR) rates
  time frame: 12 weeks
  description: Percentage of patients who achieve pathological complete remission (pCR)
  measure: R0 resection rates
  time frame: 12 weeks
  description: The proportion of patients experiencing a R0 resection
  measure: three-year disease-free survival rate, DFS
  time frame: 3 years
  description: Percentage of patients who achieve disease-free survival lasting for more than three years
  measure: three-year Overall survival rate,OS
  time frame: 3 years
  description: Percentage of patients who achieve survival for more than two years
  measure: Incidence of Treatment-Related Adverse Events
  time frame: 3 years
  description: Number of adverse events.
  arm group label: PD-1 inhibitor
  arm group type: Experimental
  description: Neoadjuvant therapy with PD-1 inhibitor (Toripalimab)
  intervention type: Drug
  intervention name: PD-1 inhibitor
  description: 240mg, Q3W. The opportunity for surgery was evaluated after 2 cycles of treatment and surgical treatment was performed after 2-4 cycles of treatment. Postoperatively, adjuvant therapy was continued according to the neoadjuvant regimen, and direct treatment met the criteria for termination of treatment.
  arm group label: PD-1 inhibitor
  other name: Toripalimab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Dongsheng Zhang, PhD
  role: Principal Investigator
  affiliation: Sun Yat-sen University
  last name: Dongsheng Zhang, PhD
  phone: 86-2087343795
  email: zhangdsh@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Dong sheng Zhang
  investigator title: Professor
  mesh term: Adenocarcinoma
  mesh term: Esophageal Neoplasms
  mesh term: Immune Checkpoint Inhibitors