NCT01616849已完成2 期
Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
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 nasopharyngeal carcinoma
- •Distance metastasis at least 6 months after radical treatment
- •Not suitable for local treatment, e.g. surgery, TACE
- •At least one measurable lesion
- •Estimate survival >3months
- •Range from 18～70 years old
- •WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- •ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
- •0Serum creatinine < 1.5×ULN
排除标准
- •Central nervous system metastases
- •Suitable for local treatment
- •Second malignancy within 5 years
- •Precious therapy with an investigational agent
- •Uncontrolled seizure disorder or other serious neurologic disease
- •≥ Grade Ш allergic reaction to any drug including in this study
- •Clinically significant cardiac or respiratory disease
- •Creatinine clearance < 30ml/min
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Severe complication, active infection
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Pregnancy or lactation
研究组 & 干预措施
PF+ Nimotuzumab
Experimental
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
干预措施: cisplatin and 5-Fu combined with nimotuzumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: study period of 19 Months
To be determined by measurement of target lesions according to RECIST criteria
Progression free survival
时间窗: 19 Months
Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
次要结局
- Overall survival(19 Months)
- Quality of life(8 Months)
研究者
Zhao Chong
MD
Sun Yat-sen University
研究点 (1)
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