NCT01486992Unknown2 期
mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus
Peking University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.
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 1st line treatment of paclitaxel/cisplatin
- •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>3,500/mm3, absolute neutrophil count ≥2000/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
- •More than 1 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
Experimental
irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw
干预措施: mFOLFIRI+Nimotuzumab (Drug)
结局指标
主要结局
adverse events
时间窗: 2 weeks
overall survival
时间窗: 2 years
次要结局
- response rate(6 weeks)
- disease control rate(6 weeks)
- progression-free survival(1year)
研究者
Shen Lin
HEAD OF GI ONCOLOGY
Peking University
研究点 (1)
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