A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficiency
研究概览
简要总结
To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib
详细描述
Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy.
Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of <0.05 was considered statistically significant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Histopathological diagnosis of metastatic GIST.
- •. After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
- •. Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
- •at least 1 month after surgery for imatinib treatment or sunitinib treatment.
- •at least one imaging assessment was received after surgery.
- •. Complete clinical data and follow-up data.
排除标准
- •. Before operation, he was treated with sunitinib
- •. Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
- •. The treatment of imatinib or sunitinib after surgery was less than 1 month.
- •. Incomplete clinical data or follow-up data.
研究组 & 干预措施
Arm B
Sunitinib 37.5 mg/day, continuous taking, or 50 mg/day (4/2), began within 6 weeks after surgery, and was continuously administered until tumor progression, recurrence or adverse reactions were not tolerated
干预措施: Sunitinib 37.5Mg Oral Capsule (Drug)
Arm A
Imatinib 400 mg/day or 600mg/day, and within 6 weeks after surgery, continuous treatment was not tolerated until tumor progression, recurrence or adverse reactions were not tolerated.
干预措施: Imatinib 400mg (Drug)
结局指标
主要结局
Efficiency
时间窗: 12 months
The curative effect was evaluated by measuring the unprogression-survival (PFS) each treatment group.
Security
时间窗: 12 months
Clinical and laboratory toxicity/symptoms will be graded according to the nci-ctc toxicity criteria.
Molecular marker detection
时间窗: 12 months
Gene mutation of c-kit/PDGFRA of imatinib resistance
次要结局
未报告次要终点
研究者
Shen Lin
Professor
Peking University