Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Progression free survival（PFS）
研究概览
简要总结
The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative histologically confirmed primary gastrointestinal stromal tumor
- •Tumor must stain positive for c-Kit (CD117) and/or discovered on gist-1 (DOG-1) by immunohistochemistry
- •Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18
- •High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter> 10.0cm), nonstomach (maximum tumor diameter> 5.0cm)
- •Gender is not limited. Age: ≥ 18 years and ≤ 80 years old
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
- •Patient had informed consent and signed a written consent form
排除标准
- •Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18), or c-kit exon 9 mutation
- •Treated with tyrosine kinase inhibitors including Imatinib
- •Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)>2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)>1.5×ULN，or Creatinine (Cr)>1.0×ULN
- •Absolute neutrophil count (ANC) < 1.5 × 10 ^ 9 / L；or Platelet count (PLT) < 75 × 10 ^ 9 / L；or Hemoglobin (Hb) ≥ 90 g / L
- •Previous or concurrent other active malignant tumors (except for basal cell carcinoma of the skin, or cervical cancer in situ that has undergone curative therapy)
- •Distant metastases are present
- •Any of the following conditions during the 12 months prior to entry: myocardial infarction, severe / unstable angina, coronary artery / peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accidents
- •positive Human Immunodeficiency Virus (HIV) antibody
- •Currently participating in other clinical trials
- •Pregnant or lactating women or have fertility without taking contraception
- •Suffering from other serious acute and chronic physical or mental problems, or abnormal laboratory tests, will increase the risk of participation or drug use, or interfere with the judgment of the findings, judged by the researchers as participate in the study
研究组 & 干预措施
Imatinib neoadjuvant
Patients receive oral imatinib mesylate 400mg once daily for 3-12 months in the absence of disease progression or unacceptable toxicity. Within 1 week after completion of preoperative imatinib mesylate, patients with responding or stable disease undergo surgical resection. After complete resection, patients receive oral imatinib mesylate 400mg once daily for 36 months in the absence of disease progression or unacceptable toxicity, and are followed for 5 years.
干预措施: Imatinib (Drug)
结局指标
主要结局
Progression free survival（PFS）
时间窗: 5 years
Progression free survival（PFS）
次要结局
- Objective Response Rate （ORR）(Up to 1 year)
- R0 resection rate(Up to 1 year)
- Overall survival（OS）(5 years)
研究者
Yu jiren
Chief of Gastrointestinal Surgery
First Affiliated Hospital of Zhejiang University