JPRN-UMIN000023646已完成2 期
A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. - A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. (PRINCIPAL study,HANSHIN 0116)
HANSHIN cancer study group0 个研究点目标入组 28 人开始时间: 2016年8月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 90years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.History of severe drug allergy 2.Side effects of previously treatment is existed and disturb safety analysis 3.urrent or previous History of auto immune disease 4.Pulmonary fibrosis detected by chest CT or clinical examination 5.current or previous history of diverticulitis or ulcerative disease of GI 6.History of active double cancer with in 5 years 7.History of pericardial effusion/ pleural effusion/ ascites with treatment needed. 8.Brain metastasis required for radiation therapy. 9.uncontrolled pain due to bone metastasis 10.Current or previous (within the last 180days) history of symptomatic cerebrovascular disease or thromboembolism. 11.Uncontrollable severe cardiovascular disease 12.Uncontrollable diabetes mellitus 13. previous (within the last 14 days) pleurodesis 14.previous (within the last 28 days) operation with systemic anesthesia 15.previous (within the last 56 days) thoracic radiation therapy with over 40Gy. 16.systemic infectious disease require treatment. 17.Active hepatitis type B or typeC 18.Sever side effect caused by previously treated immune checkpoint blockade. 19.History of active psychological disease. 20.History of dementia 21.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
研究者
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