NCT04647357Unknown2 期
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
Wuhan Union Hospital, China0 个研究点目标入组 60 人开始时间: 2020年11月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- PFS
研究概览
简要总结
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age is 18-75 years old (including both ends), regardless of gender;
- •Histologically confirmed limited stage small cell lung cancer ;
- •ECOG PS 0 ~ 1;
- •Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
- •The last chemotherapy must be finished before or at the same time of radiotherapy.
- •The disease did not progress after concurrent chemoradiotherapy;
- •The expected survival time was more than 3 months;
- •Pulmonary function: FEV1 > 70%;
排除标准
- •The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
- •Mixed SCLC or NSCLC confirmed by histology;
- •Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
- •Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
- •Extensive SCLC;
- •Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
- •Interstitial pneumonia
- •History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
- •HIV, active Hepatitis B or Hepatitis C infection
研究组 & 干预措施
SHR-1316
Experimental
干预措施: SHR-1316 (Drug)
结局指标
主要结局
PFS
时间窗: Up to approximately 24 months
progression-free survival
次要结局
未报告次要终点
研究者
Xiaorong Dong
Director
Wuhan Union Hospital, China
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