Immunotherapy, Proton Therapy
Conditions
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.
Interventions
COMBINATION_PRODUCTRadiation+PD-1 Ab
combination of proton radiotherapy with PD-1 antibody
Sponsors
YiZhou International Cancer Hospital
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through 1 years after completion of treatment | Assess adverse events according to CTCAE4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactYun Bai, MD
Outcome results
None listed