Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

Phase 1

• Conditions: Proton Therapy; Immunotherapy; Neoplasm Metastasis

• Registration Number: NCT03765190
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05
• Study Start: 2019-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events	Through 1 years after completion of treatment	Assess adverse events according to CTCAE4.0

Secondary Outcome Measures

Name	Time	Method
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.
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.