Combination of Hypofractionated Proton Therapy With Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using hypofractionated proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Detailed Description
-----------------
Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of tumor. With the development of proton radiotherapy technology, proton HFRT technique is available nowadays. However, proton HFRT technique is mainly effective in improving the local control rates. This study intends to observe the safety and efficacy of proton HFRT technique combined with immunotherapy in improving the overall anti-tumor effect.

Official Title
-----------------
A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy

Conditions
-----------------
Proton Therapy, Immunotherapy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed Unspecified Adult Solid Tumor 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
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 |