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

December 3, 2018 updated by: Xian-shu Gao, Peking University First Hospital

A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Radiation: Proton Therapy+PD-1 Ab
proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)
Combination product: Radiation: Proton Therapy+PD-1 Ab
combination of proton radiotherapy with PD-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Through 1 years after completion of treatment
Assess adverse events according to CTCAE4.0
Through 1 years after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Through 2 years after completion of treatment
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Through 2 years after completion of treatment
Overall survival (OS)
Time Frame: Through 2 years after completion of treatment
OS is defined as the duration of time from start of treatment to time of death.
Through 2 years after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

YiZhou International Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (ACTUAL)

December 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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