<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/NCT03764787</url>
  </required_header>
  <id_info>
    <org_study_id>20181203</org_study_id>
    <nct_id>NCT03764787</nct_id>
  </id_info>
  <brief_title>Combination of Hypofractionated Proton Therapy With Immunotherapy</brief_title>
  <acronym>I-HypoPT</acronym>
  <official_title>A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy</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 hypofractionated proton radiation therapy in combination with&#xD;
      immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody).&#xD;
      Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter&#xD;
      period of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy&#xD;
      (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon&#xD;
      radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of&#xD;
      tumor. With the development of proton radiotherapy technology, proton HFRT technique is&#xD;
      available nowadays. However, proton HFRT technique is mainly effective in improving the local&#xD;
      control rates. This study intends to observe the safety and efficacy of proton HFRT technique&#xD;
      combined with immunotherapy in improving the overall anti-tumor effect.&#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, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>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>
  <arm_group>
    <arm_group_label>Radiation+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+PD-1 Ab</intervention_name>
    <description>combination of proton radiotherapy with PD-1 antibody</description>
    <arm_group_label>Radiation+PD-1 Ab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed Unspecified Adult Solid Tumor&#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>
  <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/NCT03764787
org study id: 20181203
nct id: NCT03764787
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 hypofractionated proton radiation therapy in combination with
      immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody).
      Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter
      period of time.
Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy
      (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon
      radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of
      tumor. With the development of proton radiotherapy technology, proton HFRT technique is
      available nowadays. However, proton HFRT technique is mainly effective in improving the local
      control rates. This study intends to observe the safety and efficacy of proton HFRT technique
      combined with immunotherapy in improving the overall anti-tumor effect.
allocation: N/A
intervention model: Single Group Assignment
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+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+PD-1 Ab
description: combination of proton radiotherapy with PD-1 antibody
arm group label: Radiation+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
sharing ipd: No