Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.
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 esophageal squamous carcinoma,failed to first or second line chemothrepay
- •Age 18 to 75 years old
- •Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
- •Life expectancy of ≥3 month
- •Karnofsky performance status ≥80
- •WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.0 times ULN，Serum creatinine <1.0 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
- •No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
- •Normal ECG/cardiac function
- •Good compliance
- •Having signed informed consent -
排除标准
- •No previous systemic therapy for metastatic esophageal squamous carcinoma
- •Known hypersensitivity to study drugs
- •Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
- •No measurable lesions, eg. pleural fluid and ascites
- •Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
- •Chronic diarrhea
- •Mentally abnormal or disable cognition,including CNS metastasis
- •Pregnancy or lactation period
研究组 & 干预措施
Nimotuzumab
the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)
干预措施: nimotuzumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 weeks
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
次要结局
- adverse events(during the treatment in the hosptital,an expected average of 1 week)
研究者
Shen Lin
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Peking University