Efficacy and Safety of Pyrotinib in Patients With HER2 Positive Refractory or Metastatic Gastrointestinal Tumors
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Targeting human epidermal factor receptor 2 (HER2) therapy have shown the anti-tumor efficacy in patients with HER2-positive gastrointestinal tumors. Pyrotinib is an irreversible small-molecule receptor tyrosine kinase inhibitor targeting both epidermal growth factor receptor (EGFR) and HER2. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors.
详细描述
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors. Three cohorts were designed for this trial. Cohort 1: patients with gastric cancer or esophageal adenocarcinoma receiving paclitaxel combined with pyrotinib for second-line therapy; Cohort 2: patients with gastric cancer or esophageal adenocarcinoma receiving pyrotinib monotherapy for third-line or posterior line therapy; Cohort 3: patients with colorectal cancer receiving pyrotinib combined with/without trastuzumab for third-line or posterior line therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive gastrointestinal tumors who failed prior therapies.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
- •Signed informed consent.
排除标准
- •Subjects with third space fluid that can not be controled by drainage or other methods.
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- •Less than 4 weeks from the last radiotherapy, chemotherapy, target therapy
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Receiving any other antitumor therapy.
- •Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- •Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
- •Known history of neurological or psychiatric disease, including epilepsy or dementia.
研究组 & 干预措施
Pyrotinib
Pyrotinib with or without paclitaxel/trastuzumab treatment
干预措施: Pyrotinib with or without trastuzumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 24 months
evaluated in the 24th month since the treatment began
次要结局
- Progression Free Survival (PFS)(24 months)
研究者
Xiaodong Zhu
MD,PhD, Fudan University Shanghai Cancer Center
Fudan University