NCT03765190

Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proton Therapy
• Immunotherapy
• Neoplasm Metastasis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Radiation: Proton Therapy+PD-1 Ab	combination of proton radiotherapy with PD-1 antibody

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2018-12-05
• Last updated: 2018-12-05