A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Local control rate
研究概览
简要总结
This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
- •Primary treatment accepted in Chinese Academy of Medical Sciences
- •NRS score ≥2
- •Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
- •Normal organ and marrow function as defined below:
- •Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit
- •Informed consent
排除标准
- •Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- •Any prior chemotherapy or other cancer treatment prior to this protocol
- •With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
- •History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
- •Existing esophageal fistula, perforation and cachexia
- •Existing active infection such as active tuberculosis and hepatitis
- •Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- •History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- •Participation in other clinical trials currently or within 4 weeks of selection
- •Pregnant or lactating females
研究组 & 干预措施
Neoadjuvant Chemoradiotherapy（NCRT）
NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.
干预措施: Radiotherapy (Radiation)
Neoadjuvant Chemoradiotherapy（NCRT）
NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.
干预措施: Nimotuzumab (Drug)
Neoadjuvant Chemoradiotherapy（NCRT）
NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.
干预措施: S-1 (Drug)
结局指标
主要结局
Local control rate
时间窗: 1 year
次要结局
- Tumor Response rate(2-3 months)
- R0 resection rate(2-3 months)
- Overall survival(1 year, 2 year)
- ctDNA in predicting tumor response rate and prognosis(1 year, 2 year)
- Number of Participants with acute toxicities(2-3 months)
- Pathological response rate(2-3 months)
- Progression free survival(1 year, 2 year)
- Incidence of perioperative complications(2-3 months)
- Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis(1 year, 2 year)
研究者
XIN WANG
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences