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/NCT06031636</url>
    </required_header>
    <id_info>
      <org_study_id>H101 for MPM</org_study_id>
      <nct_id>NCT06031636</nct_id>
    </id_info>
    <brief_title>Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma</brief_title>
    <official_title>Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Second Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Second 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 purpose of this study is to evaluate the efficacy and safety of Oncolytic&#xD;
        Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural&#xD;
        mesothelioma who have previously been resistant to advanced PD-1 inhibitors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        By monitoring the clinical symptoms of patients with advanced immune resistant pleural&#xD;
        mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1)&#xD;
        inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus&#xD;
        drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined&#xD;
        with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the&#xD;
        drug, and finally evaluate the quality of life of patients using oncolytic adenovirus&#xD;
        injection(H101) combined with PD-1 inhibitors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ORR(Objective Response Rate)</measure>
      <time_frame>36 months</time_frame>
      <description>The proportion of CR(complete response) and PR(partial response) in all patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DCR(Disease Control Rate)</measure>
      <time_frame>36 months</time_frame>
      <description>The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS(Progression Free Survival)</measure>
      <time_frame>36 months</time_frame>
      <description>Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS(Overall Survival)</measure>
      <time_frame>36 months</time_frame>
      <description>Time between the date of grouping and death from any cause or the end of the last follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AEs(Adverse Events)</measure>
      <time_frame>36 months</time_frame>
      <description>Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Malignant Pleural Mesothelioma, Advanced</condition>
    <arm_group>
      <arm_group_label>Oncolytic adenovirus(H101) combined with PD-1 inhibitors</arm_group_label>
      <description>This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oncolytic Adenovirus H101</intervention_name>
      <description>The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles</description>
      <arm_group_label>Oncolytic adenovirus(H101) combined with PD-1 inhibitors</arm_group_label>
      <other_name>Recombinant Human Type-5 Adenovirus</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Programmed death receptor-1 inhibitor</intervention_name>
      <description>The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles</description>
      <arm_group_label>Oncolytic adenovirus(H101) combined with PD-1 inhibitors</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with malignantpleural mesothelioma who have previously been resistant to advanced&#xD;
          PD-1 inhibitors.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-75 years old (including boundary values), regardless of gender.&#xD;
  &#xD;
            2. Confirmed as late stage MPM patients who have failed immunotherapy.&#xD;
  &#xD;
            3. The patient or their legal representative can understand and sign the informed consent&#xD;
               form.&#xD;
  &#xD;
            4. At least one lesion that can safely undergo intratumoral injection or intrapleural&#xD;
               injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥&#xD;
               1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.&#xD;
  &#xD;
            5. ECOG score 0-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Physicians participating in the study believe that patients may not be able to provide&#xD;
               continuous follow-up information.&#xD;
  &#xD;
            2. Any uncontrollable clinical problems (such as severe mental, neurological,&#xD;
               cardiovascular, respiratory, and other systemic diseases).&#xD;
  &#xD;
            3. Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors,&#xD;
               etc.)&#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_contact>
      <last_name>Haitao Wang, Ph.D</last_name>
      <phone>+86-022-88326385</phone>
      <email>peterrock2000@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jinhuan Wang, Ph.D</last_name>
      <phone>+86-022-88326610</phone>
      <email>wjhhappy2008@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tianjin Medical Unversity Second Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haitao Wang, Ph.D</last_name>
        <phone>+86-022-88326385</phone>
        <email>peterrock2000@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Lili Wang, MM</last_name>
        <phone>+86-022-88326610</phone>
        <email>wangliliaigang@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Haitao Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lili Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jinhuan Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dingkun Hou</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lei Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Malignant Pleural Mesothelioma, Advanced</keyword>
    <keyword>Oncolytic Adenovirus</keyword>
    <keyword>Programmed Death Receptor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenoviridae Infections</mesh_term>
      <mesh_term>Mesothelioma</mesh_term>
      <mesh_term>Mesothelioma, Malignant</mesh_term>
    </condition_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/NCT06031636
  org study id: H101 for MPM
  nct id: NCT06031636
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy and safety of Oncolytic
        Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural
        mesothelioma who have previously been resistant to advanced PD-1 inhibitors.
  By monitoring the clinical symptoms of patients with advanced immune resistant pleural
        mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1)
        inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus
        drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined
        with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the
        drug, and finally evaluate the quality of life of patients using oncolytic adenovirus
        injection(H101) combined with PD-1 inhibitors.
  observational model: Case-Only
  time perspective: Prospective
  measure: ORR(Objective Response Rate)
  time frame: 36 months
  description: The proportion of CR(complete response) and PR(partial response) in all patients.
  measure: DCR(Disease Control Rate)
  time frame: 36 months
  description: The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.
  measure: PFS(Progression Free Survival)
  time frame: 36 months
  description: Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.
  measure: OS(Overall Survival)
  time frame: 36 months
  description: Time between the date of grouping and death from any cause or the end of the last follow-up visit.
  measure: AEs(Adverse Events)
  time frame: 36 months
  description: Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.
  arm group label: Oncolytic adenovirus(H101) combined with PD-1 inhibitors
  description: This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
  intervention type: Drug
  intervention name: Oncolytic Adenovirus H101
  description: The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles
  arm group label: Oncolytic adenovirus(H101) combined with PD-1 inhibitors
  other name: Recombinant Human Type-5 Adenovirus
  intervention type: Drug
  intervention name: Programmed death receptor-1 inhibitor
  description: The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles
  arm group label: Oncolytic adenovirus(H101) combined with PD-1 inhibitors
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Haitao Wang, Ph.D
  phone: +86-022-88326385
  email: peterrock2000@126.com
  last name: Jinhuan Wang, Ph.D
  phone: +86-022-88326610
  email: wjhhappy2008@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Adenoviridae Infections
  mesh term: Mesothelioma
  mesh term: Mesothelioma, Malignant
  sharing ipd: Undecided