Immunotherapy, Neoplasm Metastasis, 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 proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody) in multiple metastases.
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.
Interventions
COMBINATION_PRODUCTRadiation: Proton Therapy+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
Intervention model description
Proton Therapy+PD-1 Ab
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 |
|---|---|---|
| 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. |
| 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. |
Contacts
Primary ContactYun Bai, MD
Outcome results
None listed