A Phase II Trial of Neoadjuvant Chemotherapy With Nimotuzumab Plus Nanoparticle Albumin-bound Paclitaxel and Cisplatin Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.
详细描述
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.
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
- •Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
- •Locally advanced disease that is technically operable with curative intent (R0)
- •T3, N0 OR T1-3, N+ OR T4, Nx
- •No T1-2, N0
- •No inoperable T4 (unequivocal organ involvement)
- •No distant metastasis, including M1a lymph node status
- •Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
- •No carcinoma of the cervical esophagus
- •Obstructive tumors allowed
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
- •History of serious allergic or castor oil allergy
- •Patients who are not suitable to participate in the trial according to researchers
研究组 & 干预措施
Nimotuzumab nab-paclitaxel cisplatin
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.
Nab-paclitaxel: 125mg/m2,IV on days 1,8,22,29.
patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
response rate
时间窗: From date of treatment until the date of progression, assessed up to 2 months
pathological response rate and clinical response rate
次要结局
- Overall survival(Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months)
- Progression-free survival(Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months)
- Adverse events(During the chemotherapy,an expected average of 3 weeks)
研究者
Qiong Zhao
Chief of Department of Thoracic Oncology
Zhejiang University