A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 30
- Primary Endpoint
- Adverse events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically confirmed Unspecified Adult Solid Tumor
- •Intending to be treated with proton beam and immunotherapy
- •Age ≥ 18 years old
- •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
Outcomes
Primary Outcomes
Adverse events
Time Frame: Through 1 years after completion of treatment
Assess adverse events according to CTCAE4.0
Secondary Outcomes
- Overall survival (OS)(Through 2 years after completion of treatment)
- Progression-free survival (PFS)(Through 2 years after completion of treatment)
Investigators
Xian-shu Gao
Professor
Peking University First Hospital