NCT03765190

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

December 3, 2018

Last Update Submit

December 3, 2018

Conditions

Proton TherapyImmunotherapyNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Assess adverse events according to CTCAE4.0

    Through 1 years after completion of treatment

Secondary Outcomes (2)

  • Progression-free survival (PFS)

    Through 2 years after completion of treatment

  • Overall survival (OS)

    Through 2 years after completion of treatment

Study Arms (1)

Radiation: Proton Therapy+PD-1 Ab

EXPERIMENTAL

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

Combination Product: Radiation: Proton Therapy+PD-1 Ab

Interventions

Radiation: Proton Therapy+PD-1 AbCOMBINATION_PRODUCT

combination of proton radiotherapy with PD-1 antibody

Radiation: Proton Therapy+PD-1 Ab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xianshu Gao, MD,PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Bai, MD

CONTACT

(+86)010 8357564108043@pkufh.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Proton Therapy+PD-1 Ab
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 5, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

December 5, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share