尼妥珠单抗联合放化疗治疗不可切除的局部晚期鳞状细胞肺癌
2021年2月8日 更新者：Hui Liu、Sun Yat-sen University
尼妥珠单抗联合放化疗治疗不可切除局部晚期鳞状细胞肺癌的前瞻性随机Ⅱ期研究
这项 II 期随机研究旨在确定尼妥珠单抗联合放化疗治疗不可切除的局部晚期鳞状细胞肺癌的疗效和毒性。
研究概览
详细说明
这项 II 期随机研究旨在确定尼妥珠单抗联合放化疗治疗不可切除的局部晚期鳞状细胞肺癌的疗效和毒性。
所有患者计划接受根治性剂量的胸部放疗和每周多西他赛和顺铂的同步化疗，每次持续 1 天。
尼妥珠单抗组每周给予尼妥珠单抗（200mg，IV）联合放化疗，对照组给予放化疗。
研究类型
介入性
注册 (实际的)
122
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510000
- Sun Yat-sen University Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 组织学证实的鳞状细胞肺癌
- 根据实体瘤反应评估标准 (RECIST) 标准，患者具有可测量或可评估的病变
- 经 CT 或 MRI 证实的不可切除的 IIIA(N2) 期和 IIIB 期肺癌
- ECOG 体能状态 0-1
- 以前接受过化疗或未接受过治疗
- 以前没有进行过胸部放疗、免疫治疗或生物治疗。
- 血红蛋白≥10 mg/dL，血小板≥100000/μL，中性粒细胞绝对计数≥1500/μL
- 血清肌酐≤1.25倍正常上限（UNL），或肌酐清除率≥60 ml/min
- 胆红素≤1.5倍UNL，AST（SGOT）≤2.5倍UNL，ALT（SGPT）≤2.5倍UNL，碱性磷酸酶≤5倍UNL
- FEV1 >0.8 升
- CB6 在正常范围内
- 患者及家属签署知情同意书
排除标准：
- 腺鳞癌
- 既往或近期患过另一种恶性肿瘤，非黑色素瘤皮肤癌或原位宫颈癌除外
- 化疗禁忌症
- 第一次给药前 14 天处于妊娠期、哺乳期或未进行妊娠试验的女性
- 不采取避孕措施有可能怀孕的妇女
- 出血倾向
- 在 30 天内进行其他临床试验
- 吸毒或酗酒、艾滋病患者
- 无法控制的癫痫发作或没有自控能力的精神病患者
- 严重过敏或异质
- 不适合研究人员判断的这项研究
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：尼妥珠单抗
每日胸部放疗，每周多西他赛和顺铂同步化疗，每周同步尼妥珠单抗。
|
患者每周接受尼妥珠单抗（200 毫克，静脉注射）并同时进行放化疗。
患者每周接受多西紫杉醇和顺铂，每次持续 1 天，同时进行胸部放疗
患者每天接受胸部放疗
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有源比较器：控制
每日胸部放疗，每周多西紫杉醇和顺铂同步化疗。
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患者每周接受多西紫杉醇和顺铂，每次持续 1 天，同时进行胸部放疗
患者每天接受胸部放疗
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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总生存期
大体时间：3年
|
3年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
无进展生存期
大体时间：3年
|
3年
|
|
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客观反应率
大体时间：3年
|
3年
|
|
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3-4级放射性食管炎的发生率
大体时间：1年
|
由 CTCAE v4.0 评估的 3-4 级放射性食管炎发生率
|
1年
|
|
3-4级放射性肺炎发生率
大体时间：1年
|
CTCAE v4.0 评估的 3-4 级放射性肺炎发生率
|
1年
|
|
失败模式
大体时间：3年
|
局部区域复发率、远处转移率和脑转移率
|
3年
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (实际的)
2020年6月1日
研究完成 (实际的)
2020年10月1日
研究注册日期
首次提交
2015年10月12日
首先提交符合 QC 标准的
2015年10月14日
首次发布 (估计)
2015年10月16日
研究记录更新
最后更新发布 (实际的)
2021年2月11日
上次提交的符合 QC 标准的更新
2021年2月8日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.