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临床试验/NCT06628739
NCT06628739已完成不适用

Correlation Between Imatinib Trough Concentration and Efficacy in Advanced Gastrointestinal Stromal Tumors Patients with Different Genotypes

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

Imatinib (IM) has significantly enhanced the prognosis of patients (pts) with advanced gastrointestinal stromal tumors (GISTs). The clinical outcomes may correlate with IM exposure. However, the efficacy threshold, particularly based on different primary KIT mutant, remains undefined. The objective of this study is to establish the efficacy threshold of imatinib (IM) plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.

详细描述

Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. The majority of GIST are driven by activating mutuations of KIT (60-70%) or platelet-derived growth factor receptor alpha (PDGFRA, 10-15%), in which KIT exon 11 mutation (52-58%) and KIT exon 9 mutation (6-9%) are the most common types of KIT mutations. Patients with different activating KIT mutations have different sensitivity to imatinib therapy. In the first-line therapy, patients with KIT exon 11 mutation receiving Imatinib with standard dose of 400mg/d has the best therapeutic effect. Patients with KIT exon 9 mutation have poor sensitivity to the standard dose of imatinib, while higher doses can lead to better outcomes. The clinical outcomes may correlate with IM exposure. However, the efficacy threshold of imatinib in Chinese patients with advanced GIST remains unclear. The investigators aim to establish the efficacy threshold of imatinib plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed metastatic or recurrent GIST
  • Aged 18 or older
  • Treated with imatinib as first-line therapy
  • Had imatinib Cmin measurement at steady state(at least one month after treatment) ≥2 times under long-term maintenance dose of regular medication
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2

排除标准

  • Poor appliance
  • Important treatment data missing
  • Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal

结局指标

主要结局

Progression free survival

时间窗: through study completion, an average of 1 year

Progression free survival (PFS) was defined as time from initiation of imatinib treatment until disease progression, as assessed by Choi criteria, or death caused by any reason.

次要结局

  • objective response rate(through study completion, an average of 1 year)
  • Overall survival(through study completion, an average of 1 year)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinhua Zhang, MD

Deputy Director

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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