NCT01336049Unknown2 期
Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Peking University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年3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
- 70
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before,the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Having signed informed consent
- •Age 18 to 75 years old
- •Histologically confirmed esophageal squamous carcinoma, Unresectable recurrent or metastatic disease,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months,recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of paclitaxel as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
- •Sex is not limited
- •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)
- •Karnofsky performance status ≥80
- •Life expectancy of ≥ 3 month
- •WBC > 4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet > 100,000/mm3, Hb > 10g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.0 times ULN
- •No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃；
- •Normal ECG and heart function
- •Fertile patients must use effective contraception
- •Good compliance
排除标准
- •Previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
- •Known hypersensitivity to Nimotuzumab,Paclitaxel,Cisplatin
- •Only with Brain or bone metastasis
- •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
- •Suffer from severe heart disease or disease with other important organs
- •Chronic diarrhea or renal dysfunction
- •Pregnancy or lactation period
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Chronic diarrhea
- •Mentally abnormal or disable cognition,including CNS metastasis
研究组 & 干预措施
Nimotuzumab
Experimental
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
- overall survival of all participants(2 years)
- progression free survival(1 year)
- adverse events(participants will be followed for the duration of hospital stay, an expected average of 1 week)
研究者
研究点 (1)
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