Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer (PI-MMC)

Peking University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Immunotherapy; Proton Therapy; Neoplasm Metastasis

Treatments: Combination Product: Radiation: Proton Therapy+PD-1 Ab

Study type: Interventional

Funder types: Other

Identifiers

NCT03765190

20181204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Radiation: Proton Therapy+PD-1 Ab

Experimental group

Description:

proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)

Treatment:

Combination Product: Radiation: Proton Therapy+PD-1 Ab