Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
2012年9月19日 更新者：Zhejiang Cancer Hospital
A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer.
And neoadjuvant chemotherapy may improve overall survival after surgical resection.
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR).
The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity
研究概览
地位
未知
详细说明
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases.
A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone.
The neoadjuvant chemotherapy may improve overall survival.
Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively.
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR).
The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab.
The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.
研究类型
介入性
注册 (预期的)
60
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
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310022
- 招聘中
- Zhejiang Cancer Hospital
-
接触：
- Yun Fan, doctor
- 电话号码：0086-571-88122192
- 邮箱：fanyun@csco.org.cn
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首席研究员：
- Weimin Mao, doctor
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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 70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
Inclusion Criteria:
- Histological or cytologic diagnosis of Esophageal squamous cell carcinoma
- ECOG performance status 0-2
- Age:18-70 years
- Joined the study voluntarily and signed informed consent form
- Patients must not have received any prior anticancer therapy
- Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009）
- Target lesions can be measured according to RECIST criteria
- No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
- Use of an effective contraceptive for adults to prevent pregnancy
- Life expectancy of more than 3 months
Exclusion Criteria:
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction，Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Nimotuzumab plus chemotherapy
|
Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22 paclitaxel: 90mg/m2, IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathology complete remission rate
大体时间：1 year
|
Pathology complete remission rate is the primary outcome measure.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
总生存期
大体时间：5年
|
5年
|
|
|
R0切除率
大体时间：1年
|
1年
|
|
|
objective response rate
大体时间：1 year
|
Objective response rate of neoadjuvant chemotherapy will be assessed.
|
1 year
|
|
tolerability and safety
大体时间：2 years
|
number of adverse events such as leucopenia ,rash,diarrhea and so on
|
2 years
|
|
Quality of life
大体时间：5 years
|
Quality of life of patients will be evaluated during and after therapy.
|
5 years
|
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。
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
2012年9月1日
初级完成 (预期的)
2013年9月1日
研究完成 (预期的)
2017年9月1日
研究注册日期
首次提交
2012年9月16日
首先提交符合 QC 标准的
2012年9月19日
首次发布 (估计)
2012年9月20日
研究记录更新
最后更新发布 (估计)
2012年9月20日
上次提交的符合 QC 标准的更新
2012年9月19日
最后验证
2012年9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.