The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer
A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Yanhua Huang
- 电话号码:0518-82342973
- 邮箱:Yanhua.Huang@hengrui.com
学习地点
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200000
- Shanghai Pulmonary Hospital
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首席研究员:
- Chang Chen
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
- At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
The ECOG score was 0 or 1. 4. Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection.
5.Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.
6.Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.
7.According to the RECIST v1.1 standard, subjects must have measurable target lesions examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first administration.
8.There is sufficient hematology and organ function, as defined by the results of laboratory tests, to be completed within 7 days prior to the first dose of treatment : 9.Women of childbearing age must have a serum pregnancy test within 7 days before the first administration, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use an efficient method of contraception from the date of signing the informed consent to at least 26 weeks ( female subjects ) or 14 weeks ( male subjects ) after the last administration.
Exclusion Criteria:
- Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.
3.Have previously received systematic anti-tumor therapy for non-small cell lung cancer other than this study ( including clinical research drugs ) ; 4.Participants who had received or planned to receive local treatment such as chest radiotherapy or ablation ;
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 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:PART A
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Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection
|
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实验性的:PART B
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Adebrelimab Injection combined with HRS-7058 Capsule
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.
大体时间:All results are expected to be obtained in the last participant three months after surgery.
|
All results are expected to be obtained in the last participant three months after surgery.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Event-free survival (EFS)
大体时间:In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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EFS is defined as the time from the first dose to any of the following events: any progression of disease precluding surgery; progression or recurrent disease based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after surgery; or death from any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
|
Disease-free survival (DFS) as assessed byinvestigator
大体时间:In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
DFS is defined as the time from firste dose to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
|
Objective response rate (ORR): assessed by the investigator
大体时间:In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
|
|
Overall Survival (OS)
大体时间:In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
OS is defined as the time from first dose to death due to any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SHR-1316-207
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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