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Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer (PI-MMC)

Primary Purpose

Proton Therapy, Immunotherapy, Neoplasm Metastasis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Radiation: Proton Therapy+PD-1 Ab
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proton Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed Unspecified Adult Solid Tumor
  • Multiple metastatic tumors
  • Intending to be treated with proton beam and immunotherapy
  • Age ≥ 18 years old
  • KPS≥70
  • Signed written informed consent.

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient under guardianship or tutorship
  • Patients or legal guardians who are unable to understand informed consent document

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiation: Proton Therapy+PD-1 Ab

    Arm Description

    proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)

    Outcomes

    Primary Outcome Measures

    Adverse events
    Assess adverse events according to CTCAE4.0

    Secondary Outcome Measures

    Progression-free survival (PFS)
    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
    Overall survival (OS)
    OS is defined as the duration of time from start of treatment to time of death.

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    December 3, 2018
    Sponsor
    Peking University First Hospital
    Collaborators
    YiZhou International Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03765190
    Brief Title
    Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer
    Acronym
    PI-MMC
    Official Title
    A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University First Hospital
    Collaborators
    YiZhou International Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proton Therapy, Immunotherapy, Neoplasm Metastasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Proton Therapy+PD-1 Ab
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiation: Proton Therapy+PD-1 Ab
    Arm Type
    Experimental
    Arm Description
    proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)
    Intervention Type
    Combination Product
    Intervention Name(s)
    Radiation: Proton Therapy+PD-1 Ab
    Intervention Description
    combination of proton radiotherapy with PD-1 antibody
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    Assess adverse events according to CTCAE4.0
    Time Frame
    Through 1 years after completion of treatment
    Secondary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Description
    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
    Time Frame
    Through 2 years after completion of treatment
    Title
    Overall survival (OS)
    Description
    OS is defined as the duration of time from start of treatment to time of death.
    Time Frame
    Through 2 years after completion of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologically confirmed Unspecified Adult Solid Tumor Multiple metastatic tumors Intending to be treated with proton beam and immunotherapy Age ≥ 18 years old KPS≥70 Signed written informed consent. Exclusion Criteria: Pregnant or breastfeeding woman Patient under guardianship or tutorship Patients or legal guardians who are unable to understand informed consent document
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun Bai, MD
    Phone
    (+86)010 83575641
    Email
    08043@pkufh.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xianshu Gao, MD,PhD
    Organizational Affiliation
    Peking University First Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

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