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

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03765190

Collaborator

YiZhou International Cancer Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Proton Therapy Immunotherapy Neoplasm Metastasis	Combination Product: Radiation: Proton Therapy+PD-1 Ab	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Proton Therapy+PD-1 AbProton Therapy+PD-1 Ab

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse events [Through 1 years after completion of treatment]
Assess adverse events according to CTCAE4.0

Secondary Outcome Measures

Progression-free survival (PFS) [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.
Overall survival (OS) [Through 2 years after completion of treatment]
OS is defined as the duration of time from start of treatment to time of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University First Hospital
YiZhou International Cancer Hospital

Investigators

Principal Investigator: Xianshu Gao, MD,PhD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xian-shu Gao, Professor, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT03765190

Other Study ID Numbers:

20181204

First Posted:

Dec 5, 2018

Last Update Posted:

Dec 5, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Dec 5, 2018