Combination of Hypofractionated Proton Therapy With Immunotherapy

Phase 1

• Conditions: Immunotherapy; Proton Therapy
• Interventions: Combination Product: Radiation+PD-1 Ab

• Registration Number: NCT03764787
• 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 hypofractionated proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Detailed Description

Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of tumor. With the development of proton radiotherapy technology, proton HFRT technique is available nowadays. However, proton HFRT technique is mainly effective in improving the local control rates. This study intends to observe the safety and efficacy of proton HFRT technique combined with immunotherapy in improving the overall anti-tumor effect.

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: 2021-01-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

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

Inclusion Criteria

• Pathologically confirmed Unspecified Adult Solid Tumor
• 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

Arm && Interventions

Group	Intervention	Description
Radiation+PD-1 Ab	Radiation+PD-1 Ab	proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)

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
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.
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.