A Phase 1/2 interventional study of Radiation: Proton Therapy+PD-1 Ab in Proton Therapy, Immunotherapy and Neoplasm Metastasis, sponsored by Peking University First Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Peking University First Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
3,562 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.
This study's planned enrollment of 30 is below the median of 54 across 2,800 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)
Combination Product: Radiation: Proton Therapy+PD-1 Ab
combination of proton radiotherapy with PD-1 antibody
Adverse events
Assess adverse events according to CTCAE4.0
Time frame: Through 1 years after completion of treatment
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.
Time frame: 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.
Time frame: Through 2 years after completion of treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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