A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pathology complete remission rate
研究概览
简要总结
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
详细描述
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nimotuzumab plus chemotherapy
干预措施: Nimotuzumab combined with paclitaxel and cisplatin (Drug)
结局指标
主要结局
Pathology complete remission rate
时间窗: 1 year
Pathology complete remission rate is the primary outcome measure.
次要结局
- R0 resection rate(1 year)
- objective response rate(1 year)
- overall survival(5 years)
- tolerability and safety(2 years)
- Quality of life(5 years)