NCT01483014已完成2 期
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Objective response using the RECIST criteria
研究概览
简要总结
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
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
- •patients with age between 18 and 80 years
- •diagnosis of GIST not previously treated
- •Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)
- •Exclusion criteria:
- •presence of metastatic disease
- •use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
- •Other protocol-defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
imatinib
Experimental
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Objective response using the RECIST criteria
时间窗: 16 weeks
次要结局
- Progression free survival(16 weeks)
- Time and duration of response(16 weeks)
- Overall survival(16 weeks)
- Time to treatment failure(16 weeks)
研究者
研究点 (2)
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