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/NCT05982834</url>
    </required_header>
    <id_info>
      <org_study_id>FDZL-RCPF</org_study_id>
      <nct_id>NCT05982834</nct_id>
    </id_info>
    <brief_title>Disitamab Vedotin, Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive MGC</brief_title>
    <official_title>Disitamab Vedotin Combined With Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive Metastatic Gastric Cancer: A Prospective Phase Ib/II Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan 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>
        At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment&#xD;
        of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with&#xD;
        anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its&#xD;
        cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs.&#xD;
        Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of&#xD;
        KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from&#xD;
        immunotherapy, so the investigators hope to explore the possibility of immunotherapy in&#xD;
        second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to&#xD;
        enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of&#xD;
        the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in&#xD;
        second-line therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
    <phase>Phase 1/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>objective response rate</measure>
      <time_frame>8 weeks, up to 1 year.</time_frame>
      <description>the proportion of patients whose tumor dcrease to a certain size and remained for a certain period of time, including those with complete response(CR) and partial response (PR).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">43</enrollment>
    <condition>HER2-positive Gastric Cancer</condition>
    <condition>Immunotherapy</condition>
    <arm_group>
      <arm_group_label>Disitamab Vedotin combined with fruquintinib and Tislelizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Disitamab Vedotin combined with fruquintinib and Tislelizumab</intervention_name>
      <description>Disitamab Vedotin 2.5mg/m2 ivgtt d1,15, fruquintinib 4mg qd po d1-21 and Tislelizumab 300mg ivgtt,q4w</description>
      <arm_group_label>Disitamab Vedotin combined with fruquintinib and Tislelizumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. older than18 years of age, gender not limited;&#xD;
  &#xD;
            2. the histologic diagnosis of the stomach or gastroesophageal junction adenocarcinoma;&#xD;
  &#xD;
            3. immunohistochemical HER2 2 + 3 + or HER2, FISH is positive;&#xD;
  &#xD;
            4. at least have a measurable lesions (10 mm or higher spiral CT scan, RECIST 1.1&#xD;
               standard);&#xD;
  &#xD;
            5. First-line treatment failure of fluorouracil and the platinum, or to accept containing&#xD;
               fluorouracil and platinum adjuvant chemotherapy in patients with recurrence after 6&#xD;
               months;&#xD;
  &#xD;
            6. ECOG 0-2, expected survival for 3 months or more;&#xD;
  &#xD;
            7. the subjects treated with other damage has been restored, accepting radiotherapy&#xD;
               should be ended more than 3 weeks;&#xD;
  &#xD;
            8. major organs function is normal, the group within 1 week before the lab test results&#xD;
               meet the following criteria: (1) The standard of blood routine examination shall meet:&#xD;
  &#xD;
                 1. HB≥80g/L;&#xD;
  &#xD;
                 2. ANC ≥1.5×109/L;&#xD;
  &#xD;
                 3. PLT ≥75×109/L (2) Biochemical examination shall meet the following standards:&#xD;
  &#xD;
               a. Total bilirubin BIL &lt; 1.25 * upper limit of normal (ULN) B. the ALT and AST&#xD;
               acuities were 2.5 * ULN. C. serum creatinine (Cr) of 1.5 or less * ULN, endogenous&#xD;
               creatinine clearance &gt; 50 ml/min (Cockcroft - Gault formula)&#xD;
  &#xD;
            9. participants voluntarily participate in this study, and signed by himself or agent&#xD;
               informed consent; Patient compliance is good, can cooperate with the relevant&#xD;
               examination, treatment and follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. history of other malignant tumors within 3 years, have cured except cervical carcinoma&#xD;
               in situ or skin basal cell carcinoma;&#xD;
  &#xD;
            2. with brain or meningeal metastasis;&#xD;
  &#xD;
            3. associated with gastrointestinal obstruction, gastrointestinal bleeding (defecate&#xD;
               occult blood + + + and above) or perforation;&#xD;
  &#xD;
            4. with active, or have a history and possible recurrence of autoimmune disease of the&#xD;
               subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory&#xD;
               bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis,&#xD;
               glomerulonephritis, etc.), or those at high risk (such as those who have received an&#xD;
               organ transplant requiring immunosuppressive therapy), However, patients with&#xD;
               vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic&#xD;
               treatment within the last 2 years, or patients with hypothyroidism who only needed&#xD;
               thyroid hormone replacement therapy, and patients with type I diabetes who only needed&#xD;
               insulin replacement therapy could be enrolled;&#xD;
  &#xD;
            5. now with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung&#xD;
               diseases, radiation pneumonia;&#xD;
  &#xD;
            6. within 4 weeks before delivery for the first time to participate in any other drug&#xD;
               clinical research (the use of test drugs shall prevail), unless the participant&#xD;
               observation (non intrusive) clinical research;&#xD;
  &#xD;
            7. within 4 weeks before the first dose of study treatment used immunosuppressive drugs,&#xD;
               Does not include nasal, inhalation or other routes of topical corticosteroids or&#xD;
               physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/ day of&#xD;
               prednisone or equivalent doses of other corticosteroids), or short-term (not exceeding&#xD;
               7 days) use of corticosteroids for the prevention or treatment of non-autoimmune&#xD;
               allergic diseases;&#xD;
  &#xD;
            8. within 4 weeks before the first dose of study treatment or accept the live attenuated&#xD;
               plan during the study period. Note: Inactivated virus vaccines for injectable seasonal&#xD;
               influenza are permitted for up to 4 weeks prior to initial administration; But live&#xD;
               attenuated influenza vaccines are not allowed;&#xD;
  &#xD;
            9. within 4 weeks before the first dose of study treatment received major surgery, open&#xD;
               chest or craniotomy laparotomy or expected during the research and treatment need to&#xD;
               accept of this study major surgery.&#xD;
  &#xD;
           10. infected with human immunodeficiency virus (HIV) disease (i.e., an HIV positive), or&#xD;
               with other acquired, congenital immunodeficiency disease, or has a history of history&#xD;
               of organ transplantation, or stem cell transplantation;&#xD;
  &#xD;
           11. chronic active hepatitis b or active active hepatitis c, hepatitis b virus carriers,&#xD;
               stable after drug treatment of hepatitis b (DNA drop degree is not higher than 200&#xD;
               iu/mL or copy number Copies &lt;1000copies/mL) and cured hepatitis C patients (HCV RNA&#xD;
               test negative) could be included;&#xD;
  &#xD;
           12. with known active tuberculosis;&#xD;
  &#xD;
           13. first before 4 weeks with severe infections, or 2 weeks before appear active infection&#xD;
               need oral or intravenous antibiotic therapy patients;&#xD;
  &#xD;
           14. symptomatic congestive heart failure (New York heart association grade II - IV) or&#xD;
               symptomatic or poorly controlled arrhythmia.&#xD;
  &#xD;
           15. even give specification treatment still uncontrolled arterial blood pressure (systolic&#xD;
               blood pressure or greater acuity 160 MMHG or diastolic blood pressure, 100 MMHG).&#xD;
  &#xD;
           16. within 6 months before the selected treatment occurred any arterial thromboembolic&#xD;
               events, including myocardial infarction, unstable angina, cerebrovascular accident, or&#xD;
               transient ischemic attack.&#xD;
  &#xD;
           17. within 3 months before the group with deep vein thrombosis, pulmonary embolism, or any&#xD;
               other serious history of thromboembolism (implantable venous infusion port source sex&#xD;
               or catheter thrombosis, or superficial venous thrombosis were not regarded as a&#xD;
               &quot;severe&quot; thromboembolism).&#xD;
  &#xD;
           18. always have a clear history of neurological or psychiatric disorders, such as memory,&#xD;
               epilepsy, dementia, compliance, or the peripheral nervous system disorder;&#xD;
  &#xD;
           19. alcohol dependence or nearly 1 year has a history of drug or drug abuse;&#xD;
  &#xD;
           20. pregnancy or lactation women; Those who are fertile but do not take adequate&#xD;
               contraceptive measures;&#xD;
  &#xD;
           21. may lead to the following results of other acute or chronic diseases, mental illness&#xD;
               or abnormal laboratory values: participated in or study drug dosage associated with an&#xD;
               increased risk, or interfere with the interpretation of results, and according to the&#xD;
               researcher's judgment will be patient as does not conform to participate in this&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiaodong Zhu, M.D.,Ph.D.</last_name>
      <phone>64175590</phone>
      <email>xddr001@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaodong Zhu, Ph.D.,M.D.</last_name>
        <phone>64175590</phone>
        <email>xddr001@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 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>Fudan University</investigator_affiliation>
      <investigator_full_name>Xiaodong Zhu</investigator_full_name>
      <investigator_title>Principal Investigator, Clinical Professor of the Department of Medical gastrointestinal oncology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tislelizumab</mesh_term>
      <mesh_term>Disitamab vedotin</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/NCT05982834
  org study id: FDZL-RCPF
  nct id: NCT05982834
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment
        of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with
        anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its
        cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs.
        Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of
        KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from
        immunotherapy, so the investigators hope to explore the possibility of immunotherapy in
        second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to
        enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of
        the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in
        second-line therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: objective response rate
  time frame: 8 weeks, up to 1 year.
  description: the proportion of patients whose tumor dcrease to a certain size and remained for a certain period of time, including those with complete response(CR) and partial response (PR).
  arm group label: Disitamab Vedotin combined with fruquintinib and Tislelizumab
  arm group type: Experimental
  intervention type: Drug
  intervention name: Disitamab Vedotin combined with fruquintinib and Tislelizumab
  description: Disitamab Vedotin 2.5mg/m2 ivgtt d1,15, fruquintinib 4mg qd po d1-21 and Tislelizumab 300mg ivgtt,q4w
  arm group label: Disitamab Vedotin combined with fruquintinib and Tislelizumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaodong Zhu, M.D.,Ph.D.
  phone: 64175590
  email: xddr001@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Xiaodong Zhu
  investigator title: Principal Investigator, Clinical Professor of the Department of Medical gastrointestinal oncology
  mesh term: Stomach Neoplasms
  mesh term: Tislelizumab
  mesh term: Disitamab vedotin
  sharing ipd: No