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

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.

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