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/NCT05985278</url>
    </required_header>
    <id_info>
      <org_study_id>2021KT90</org_study_id>
      <nct_id>NCT05985278</nct_id>
    </id_info>
    <brief_title>Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy</brief_title>
    <official_title>Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Cancer Hospital &amp; Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Cancer Hospital &amp; Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the retention in tumour and distribution behavior of&#xD;
        [Lu-177]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and&#xD;
        safety of [Lu-177]-Catalase.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients giving written&#xD;
        informed consent will undergo a 2-week screening period to determine eligibility for study&#xD;
        entry. At day1, patients who meet the eligibility requirements will be intratumoral injection&#xD;
        the [Lu-177]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to&#xD;
        continue intratumoral injection the [Lu-177]-Catalase, depending on the patient's efficacy&#xD;
        and safety results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2026</primary_completion_date>
    <phase>Early 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>The absorbed radiation dose of tumor and normal organs</measure>
      <time_frame>From first dose of study drug through 8 weeks post dose</time_frame>
      <description>Calculation of effective absorbed dose of tumor in situ injection</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preliminary efficacy of [ Lu-177]-Catalase based on tumor response</measure>
      <time_frame>From first dose of study drug through 8 weeks post dose</time_frame>
      <description>Tumor volume based on RECIST 1.1.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse events for [ Lu-177]-Catalase</measure>
      <time_frame>From first dose of [ Lu-177]-Catalase through 8 weeks post dose.</time_frame>
      <description>Occurrence of adverse events for [ Lu-177]-Catalase</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Advanced Malignant Neoplasm</condition>
    <arm_group>
      <arm_group_label>[ Lu-177]-Catalase</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received [ Lu-177]-Catalase intratumoral injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[ Lu-177]-Catalase</intervention_name>
      <description>[ 177Lu]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor</description>
      <arm_group_label>[ Lu-177]-Catalase</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;&#xD;
  &#xD;
            2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer,&#xD;
               prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;&#xD;
  &#xD;
            3. Patients with advanced solid tumors who have failed or cannot tolerate standard&#xD;
               treatment;&#xD;
  &#xD;
            4. Expected survival of more than 3 months;&#xD;
  &#xD;
            5. According to the solid tumor efficacy evaluation criteria , the patient had at least&#xD;
               one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline&#xD;
               (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable for&#xD;
               intratumoral injection (the length of the lesion is at least 1 cm or equal).&#xD;
  &#xD;
            6. Blood routine and liver and kidney function meet the following criteria: Blood&#xD;
               routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT or&#xD;
               APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of&#xD;
               normal),ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤&#xD;
               4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;&#xD;
  &#xD;
            7. Women must use effective contraception during the study period and for 6 months after&#xD;
               the study (effective contraception means sterilization, intrauterine hormone devices,&#xD;
               condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men should&#xD;
               consent to subjects who must use contraception during the study period and for 6&#xD;
               months after the end of the study period;&#xD;
  &#xD;
            8. Can understand and voluntarily sign informed consent, compliance is good&#xD;
  &#xD;
          The Exclusion Criteria:&#xD;
  &#xD;
            1. Severe abnormal liver and kidney function;&#xD;
  &#xD;
            2. Pregnant, pregnant and lactating women;&#xD;
  &#xD;
            3. Can not lie flat for half an hour;&#xD;
  &#xD;
            4. Refuse to join the clinical investigator;&#xD;
  &#xD;
            5. Suffering from claustrophobia or other mental illness;&#xD;
  &#xD;
            6. Other conditions deemed unsuitable for participation in the trial by the investigator&#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>Zhi Yang</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100142</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhi Yang, PhD</last_name>
        <phone>01088196196</phone>
        <email>pekyz@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Xiaoyi GUO, PhD</last_name>
        <phone>01088196495</phone>
        <email>2216392114@bjmu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Catalase</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/NCT05985278
  org study id: 2021KT90
  nct id: NCT05985278
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the retention in tumour and distribution behavior of
        [Lu-177]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and
        safety of [Lu-177]-Catalase.
  After being informed about the study and potential risks, all patients giving written
        informed consent will undergo a 2-week screening period to determine eligibility for study
        entry. At day1, patients who meet the eligibility requirements will be intratumoral injection
        the [Lu-177]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to
        continue intratumoral injection the [Lu-177]-Catalase, depending on the patient's efficacy
        and safety results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The absorbed radiation dose of tumor and normal organs
  time frame: From first dose of study drug through 8 weeks post dose
  description: Calculation of effective absorbed dose of tumor in situ injection
  measure: Preliminary efficacy of [ Lu-177]-Catalase based on tumor response
  time frame: From first dose of study drug through 8 weeks post dose
  description: Tumor volume based on RECIST 1.1.
  measure: Adverse events for [ Lu-177]-Catalase
  time frame: From first dose of [ Lu-177]-Catalase through 8 weeks post dose.
  description: Occurrence of adverse events for [ Lu-177]-Catalase
  arm group label: [ Lu-177]-Catalase
  arm group type: Experimental
  description: Participants received [ Lu-177]-Catalase intratumoral injection
  intervention type: Drug
  intervention name: [ Lu-177]-Catalase
  description: [ 177Lu]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor
  arm group label: [ Lu-177]-Catalase
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Catalase
  sharing ipd: Undecided