<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/NCT03765190</url>
  </required_header>
  <id_info>
    <org_study_id>20181204</org_study_id>
    <nct_id>NCT03765190</nct_id>
  </id_info>
  <brief_title>Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer</brief_title>
  <acronym>PI-MMC</acronym>
  <official_title>A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>YiZhou International Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this research study is to compare the effects (good and bad) on subjects and&#xD;
      their cancer using proton radiation therapy in combination with immunotherapy(ie. Programmed&#xD;
      cell death protein 1, also known as PD-1 antibody) in multiple metastases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As is known to all, the main treatment method for metastatic tumors is systemic chemotherapy&#xD;
      and radiotherapy is merely for the purpose of palliative treatment. Recent studies have shown&#xD;
      that tumors with no more than 5 metastatic sites can still achieve satisfactory overall&#xD;
      survival by local treatments such as radiotherapy. However, for tumors with more metastatic&#xD;
      lesions, side effect is pretty high for photon radiotherapy due to the wide range of&#xD;
      irradiation. Protons might be a safe treatment means for multiple metastases cancer because&#xD;
      of the Brag peak, when the normal tissue dose can be significantly reduced. Combination of&#xD;
      proton therapy with immunotherapy can be a research direction for multiple metastatic tumors.&#xD;
      This study intends to observe the safety and efficacy of proton technique combined with&#xD;
      immunotherapy in improving the overall anti- tumor effect for metastatic tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>
    <intervention_model_description>Proton Therapy+PD-1 Ab</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through 1 years after completion of treatment</time_frame>
    <description>Assess adverse events according to CTCAE4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Through 2 years after completion of treatment</time_frame>
    <description>PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Through 2 years after completion of treatment</time_frame>
    <description>OS is defined as the duration of time from start of treatment to time of death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Proton Therapy</condition>
  <condition>Immunotherapy</condition>
  <condition>Neoplasm Metastasis</condition>
  <arm_group>
    <arm_group_label>Radiation: Proton Therapy+PD-1 Ab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Radiation: Proton Therapy+PD-1 Ab</intervention_name>
    <description>combination of proton radiotherapy with PD-1 antibody</description>
    <arm_group_label>Radiation: Proton Therapy+PD-1 Ab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed Unspecified Adult Solid Tumor&#xD;
&#xD;
          -  Multiple metastatic tumors&#xD;
&#xD;
          -  Intending to be treated with proton beam and immunotherapy&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  KPS≥70&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Patient under guardianship or tutorship&#xD;
&#xD;
          -  Patients or legal guardians who are unable to understand informed consent document&#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_official>
    <last_name>Xianshu Gao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yun Bai, MD</last_name>
    <phone>(+86)010 83575641</phone>
    <email>08043@pkufh.com</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Xian-shu Gao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03765190
org study id: 20181204
nct id: NCT03765190
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to compare the effects (good and bad) on subjects and
      their cancer using proton radiation therapy in combination with immunotherapy(ie. Programmed
      cell death protein 1, also known as PD-1 antibody) in multiple metastases.
As is known to all, the main treatment method for metastatic tumors is systemic chemotherapy
      and radiotherapy is merely for the purpose of palliative treatment. Recent studies have shown
      that tumors with no more than 5 metastatic sites can still achieve satisfactory overall
      survival by local treatments such as radiotherapy. However, for tumors with more metastatic
      lesions, side effect is pretty high for photon radiotherapy due to the wide range of
      irradiation. Protons might be a safe treatment means for multiple metastases cancer because
      of the Brag peak, when the normal tissue dose can be significantly reduced. Combination of
      proton therapy with immunotherapy can be a research direction for multiple metastatic tumors.
      This study intends to observe the safety and efficacy of proton technique combined with
      immunotherapy in improving the overall anti- tumor effect for metastatic tumors.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Proton Therapy+PD-1 Ab
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
time frame: Through 1 years after completion of treatment
description: Assess adverse events according to CTCAE4.0
measure: Progression-free survival (PFS)
time frame: Through 2 years after completion of treatment
description: PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
measure: Overall survival (OS)
time frame: Through 2 years after completion of treatment
description: OS is defined as the duration of time from start of treatment to time of death.
arm group label: Radiation: Proton Therapy+PD-1 Ab
arm group type: Experimental
description: proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)
intervention type: Combination Product
intervention name: Radiation: Proton Therapy+PD-1 Ab
description: combination of proton radiotherapy with PD-1 antibody
arm group label: Radiation: Proton Therapy+PD-1 Ab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xianshu Gao, MD,PhD
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Yun Bai, MD
phone: (+86)010 83575641
email: 08043@pkufh.com
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Xian-shu Gao
investigator title: Professor
mesh term: Neoplasm Metastasis
sharing ipd: No