A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Unspecified Adult Solid Tumor
- •Intending to be treated with proton beam and immunotherapy
- •Age ≥ 18 years old
- •Signed written informed consent.
排除标准
- •Pregnant or breastfeeding woman
- •Patient under guardianship or tutorship
- •Patients or legal guardians who are unable to understand informed consent document
结局指标
主要结局
Adverse events
时间窗: Through 1 years after completion of treatment
Assess adverse events according to CTCAE4.0
次要结局
- Overall survival (OS)(Through 2 years after completion of treatment)
- Progression-free survival (PFS)(Through 2 years after completion of treatment)
研究者
Xian-shu Gao
Professor
Peking University First Hospital