Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- response to induction therapy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
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.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
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
- •Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.
- •Age ranges from 18 to 70 years.
- •Patients must not have received any prior anticancer therapy.
- •Performance status of 0 to 1
- •Estimated life expectancy of at least 6 months.
- •Tumor can be measured according to RECIST criteria
- •Signed informed consent document on file.
- •Females with childbearing potential must have a negative serum pregnancy
- •Adequate organ function including the following:
- •Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
排除标准
- •Carcinoma at the upper part of esophagus
- •Histologic diagnosis of adenocarcinoma of esophagus.
- •Prior treatment for esophageal cancer.
- •Active infection.
- •Pregnant or breast feeding.
- •History of significant neurological or mental disorder, including seizures or dementia.
- •Prior invasive malignancy in 5 years (except for carcinoma in situ).
研究组 & 干预措施
nab-paclitaxel plus cisplatin
干预措施: albumin-bound paclitaxel plus cisplatin (Drug)
结局指标
主要结局
response to induction therapy
时间窗: 2 years
The response to induction therapy will be evaluated
次要结局
- rate of complete pathological response(2 years)
- R0 resection rate.(2 years)
- 3 years disease free and overall survival(5 years)
- safety and tolerability(From time of consent to last visit)