Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
详细描述
Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.
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
- •Age range 18-70 years old
- •ECOG performance status 0-1
- •Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
- •Adequate organ function
排除标准
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Serious uncontrolled diseases and intercurrent infection
- •Previous serious cardiac disease
研究组 & 干预措施
nimotuzumab
nimotuzumab plus PF regimen
干预措施: nimotuzumab (Drug)
nimotuzumab
nimotuzumab plus PF regimen
干预措施: PF regimen (cisplatin and 5-FU) (Drug)
结局指标
主要结局
overall response rate
时间窗: 6 weeks
次要结局
- pathologic complete response(8 weeks)