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/NCT06022276</url>
    </required_header>
    <id_info>
      <org_study_id>Nimotuzumab for Pan-cancer</org_study_id>
      <nct_id>NCT06022276</nct_id>
    </id_info>
    <brief_title>Nimotuzumab for EGFR-amplified Advanced Pan Solid Tumors</brief_title>
    <official_title>An Open ,Single Arm, Prospective and Basket Clinical Study of Nimotuzumab in the Treatment of EGFR-amplified Advanced Pan Solid Tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and Neck Cervical)</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>
      <has_dmc>Yes</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>
        To evaluate the efficacy and safety of nimotuzumab in the treatment of EGFR-amplified&#xD;
        advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck&#xD;
        Cervical).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and&#xD;
        safety of Nimotuzumab for EGFR-amplified advanced pan solid tumors&#xD;
        (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical) in the real world.&#xD;
        The amplification of the patient's EGFR can be determined by tissue-next-generation&#xD;
        sequencing (NGS), Liquid-NGS, or fluorescence in situ hybridization (FISH) . EGFR-amplified&#xD;
        status identified in any Clinical Laboratory Improvement Amendments (CLIA)-certified&#xD;
        laboratory. EGFR-amplified status also was assessed for pathogenicity in each case by&#xD;
        MTB.Meanwhile, the molecular testing results of the patient are analyzed and interpreted by&#xD;
        the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based&#xD;
        on the patient's previous treatment history, physical condition, drug accessibility, and&#xD;
        economic status. In addition, exploring molecular markers that can predict the efficacy of&#xD;
        Nimotuzumab.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</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>PFS2/PFS1</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate(ORR)</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free Survival(PFS)</measure>
      <time_frame>The last subject completes at least 24 weeks of follow-up (or disease progression).</time_frame>
      <description>The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate(DCR)</measure>
      <time_frame>Through study completion,an expected average of 1 year</time_frame>
      <description>The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival(OS)</measure>
      <time_frame>Through study completion, an expected average of 2 years.</time_frame>
      <description>The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response(DOR)</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events(AEs）</measure>
      <time_frame>Through study completion, an expected average of 2 years.</time_frame>
      <description>Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life(QoL)</measure>
      <time_frame>Through study completion, an expected average of 2 years.</time_frame>
      <description>The Quality of Life scale was used to represent patients' satisfaction with quality of life to evaluate the changes in QOL of patients before and after treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Solid Tumor</condition>
    <condition>EGFR Amplification</condition>
    <arm_group>
      <arm_group_label>Monotherapy or combination therapy based on Nimotuzumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nimotuzumab</intervention_name>
      <description>Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.</description>
      <arm_group_label>Monotherapy or combination therapy based on Nimotuzumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (left&#xD;
               colorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer,&#xD;
               hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer&#xD;
               must be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence or&#xD;
               with distant metastasis. Patients with known EGFR amplification and standard treatment&#xD;
               depletion or inability to tolerate standard treatment and disease progression. Allow&#xD;
               patients with stable symptoms of brain metastasis to be enrolled.&#xD;
  &#xD;
            2. Age 18-80 years old, both male and female. Expected life&gt;3 months.&#xD;
  &#xD;
            3. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1),&#xD;
               there should be at least one measurable lesion that has not undergone local treatment&#xD;
               such as radiotherapy (lesions located within the previous radiotherapy area, if&#xD;
               confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as&#xD;
               target lesions).&#xD;
  &#xD;
            4. It has been confirmed through NGS testing that EGFR amplification exists&#xD;
               simultaneously (all cancer species).&#xD;
  &#xD;
            5. ECOG: 0-2.&#xD;
  &#xD;
            6. Expected survival time ≥ 12 weeks.&#xD;
  &#xD;
            7. If the main organs function normally, they meet the following standards:&#xD;
  &#xD;
          (1) Blood routine examination: a. HB ≥ 90g/L;b. ANC ≥ 1.5 × 10^9/L;c. PLT ≥ 80 × 10^9/L.&#xD;
  &#xD;
          (2) Biochemical examination: a. ALB ≥ 30g/L;b. ALT and AST ≤ 2.5ULN. If there is liver&#xD;
          metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinine&#xD;
          clearance rate (CCr) ≥ 60ml/min.&#xD;
  &#xD;
          8. Women of childbearing age should agree to use contraceptive measures (such as&#xD;
          intrauterine devices, contraceptives, or condoms) during the study period and within 6&#xD;
          months after the end of the study. Within 7 days prior to enrollment in the study, the&#xD;
          serum or urine pregnancy test was negative and must be a non-lactating patient. Men should&#xD;
          agree to patients who must use contraception during the study period and within 6 months&#xD;
          after the end of the study period.&#xD;
  &#xD;
          9. The subjects voluntarily joined this study, signed an informed consent form, had good&#xD;
          compliance, and cooperated with follow-up.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. The patient has any active autoimmune disease or autoimmune disease (For example, but&#xD;
               not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,&#xD;
               hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patients&#xD;
               with vitiligo. asthma that has completely relieved in childhood and does not require&#xD;
               any intervention in adulthood can be included. asthma that requires medical&#xD;
               intervention with bronchodilators cannot be included).&#xD;
  &#xD;
            2. The patient is currently using systemic hormone therapy to achieve immunosuppressive&#xD;
               effects (dosage&gt;10mg/day of prednisone or other therapeutic hormones) and continues to&#xD;
               use it within 2 weeks before enrollment.&#xD;
  &#xD;
            3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase&#xD;
               inhibitors.&#xD;
  &#xD;
            4. Patients with any severe and/or uncontrollable diseases, including:&#xD;
  &#xD;
               Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg or&#xD;
               diastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardial&#xD;
               ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I&#xD;
               cardiac dysfunction. Active or uncontrollable serious infections. Liver diseases such&#xD;
               as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10^4 copies/ml or&#xD;
               2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher&#xD;
               than the detection limit of the analytical method).&#xD;
  &#xD;
            5. Patients whose imaging shows that the tumor has invaded important blood vessels or who&#xD;
               have been determined by the researchers to be highly likely to invade important blood&#xD;
               vessels and cause fatal massive bleeding during subsequent studies.&#xD;
  &#xD;
            6. Pregnant or lactating women.&#xD;
  &#xD;
            7. Patients with other malignant tumors within 5 years (excluding cured skin basal cell&#xD;
               carcinoma and cervical carcinoma in situ).&#xD;
  &#xD;
            8. Patients who have a history of abuse of psychotropic substances and are unable to quit&#xD;
               or have mental disorders.&#xD;
  &#xD;
            9. Patients who have participated in clinical trials of other drugs within four weeks.&#xD;
  &#xD;
           10. Researchers believe that it is not suitable for inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>HaiTao Wang, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Medical University Second Hospital</affiliation>
    </overall_official>
    <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>Lili Wang, Ph.D</last_name>
      <phone>+86-022-88326610</phone>
      <email>wangliliaigang@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tianjin Medical University Second Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300211</zip>
          <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>Jinhuan Wang, Ph.D</last_name>
        <phone>+86-18602249531</phone>
        <email>wjhhappy2008@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Haitao Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jinhuan Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lili Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dingkun Hou</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Solid Tumor</keyword>
    <keyword>Nimotuzumab</keyword>
    <keyword>EGFR</keyword>
    <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>Nimotuzumab</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/NCT06022276
  org study id: Nimotuzumab for Pan-cancer
  nct id: NCT06022276
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the efficacy and safety of nimotuzumab in the treatment of EGFR-amplified
        advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck
        Cervical).
  Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and
        safety of Nimotuzumab for EGFR-amplified advanced pan solid tumors
        (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical) in the real world.
        The amplification of the patient's EGFR can be determined by tissue-next-generation
        sequencing (NGS), Liquid-NGS, or fluorescence in situ hybridization (FISH) . EGFR-amplified
        status identified in any Clinical Laboratory Improvement Amendments (CLIA)-certified
        laboratory. EGFR-amplified status also was assessed for pathogenicity in each case by
        MTB.Meanwhile, the molecular testing results of the patient are analyzed and interpreted by
        the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based
        on the patient's previous treatment history, physical condition, drug accessibility, and
        economic status. In addition, exploring molecular markers that can predict the efficacy of
        Nimotuzumab.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PFS2/PFS1
  time frame: Through study completion, an expected average of 1 year
  description: The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.
  measure: Objective Response Rate(ORR)
  time frame: Through study completion, an expected average of 1 year
  description: The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.
  measure: Progression-free Survival(PFS)
  time frame: The last subject completes at least 24 weeks of follow-up (or disease progression).
  description: The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
  measure: Disease control rate(DCR)
  time frame: Through study completion,an expected average of 1 year
  description: The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.
  measure: Overall survival(OS)
  time frame: Through study completion, an expected average of 2 years.
  description: The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
  measure: Duration of Response(DOR)
  time frame: Through study completion, an expected average of 1 year
  description: Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
  measure: Adverse events(AEs）
  time frame: Through study completion, an expected average of 2 years.
  description: Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.
  measure: Quality of Life(QoL)
  time frame: Through study completion, an expected average of 2 years.
  description: The Quality of Life scale was used to represent patients' satisfaction with quality of life to evaluate the changes in QOL of patients before and after treatment
  arm group label: Monotherapy or combination therapy based on Nimotuzumab
  arm group type: Experimental
  description: Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
  intervention type: Drug
  intervention name: Nimotuzumab
  description: Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
  arm group label: Monotherapy or combination therapy based on Nimotuzumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: HaiTao Wang, Ph.D
  role: Principal Investigator
  affiliation: Tianjin Medical University Second Hospital
  last name: HaiTao Wang, Ph.D
  phone: +86-022-88326385
  email: peterrock2000@126.com
  last name: Lili Wang, Ph.D
  phone: +86-022-88326610
  email: wangliliaigang@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Nimotuzumab