Immunotherapy Clinical Trial
— I-HypoPTOfficial title:
A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | YiZhou International Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Assess adverse events according to CTCAE4.0 | Through 1 years after completion of treatment | |
Secondary | 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 | |
Secondary | 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 |
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