A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer
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 proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody) in multiple metastases.
详细描述
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.
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
- •Multiple metastatic tumors
- •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
研究组 & 干预措施
Radiation: Proton Therapy+PD-1 Ab
proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)
干预措施: Radiation: Proton Therapy+PD-1 Ab (Combination Product)
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
- Progression-free survival (PFS)(Through 2 years after completion of treatment)
- Overall survival (OS)(Through 2 years after completion of treatment)
研究者
Xian-shu Gao
Professor
Peking University First Hospital