CTIS2024-515432-71-00进行中（未招募）1 期
Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Man or woman 18 years old or over and Performance Status: 0-2, No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years, Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen 2006], Subject with Genomic Grade Index higher than 10 determined by CGH array, Subject with surgery for primary tumor performed from 2 weeks to 3 months before starting adjuvant Imatinib mesylate, Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1), Subjects with absence of distant metastases
排除标准
- •Subjects meeting any of the following criteria must not be enrolled, Minors or pregnant or breast-feeding women., Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of the excipients (ambivalence clause), Subject treated with medicinal products that induce CYP3A4, Subject who have experienced spontaneous tumor rupture before surgery (risk of spread), Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block, Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block
研究者
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