Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasm Metastasis, Proton Therapy, Immunotherapy

Intervention / Treatment
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* Combination Product: Radiation: Proton Therapy+PD-1 Ab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Proton Therapy+PD-1 Ab
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation: Proton Therapy+PD-1 Ab<br>proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year) | Combination Product: Radiation: Proton Therapy+PD-1 Ab<br>* combination of proton radiotherapy with PD-1 antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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) | 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) | OS is defined as the duration of time from start of treatment to time of death. | Through 2 years after completion of treatment |