jRCT2080222112已完成3 期
A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double-blind, placebo-controlled, randomized, multicenter study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
- •Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Life expectancy >/= 3 months
排除标准
- •Previous cytotoxic chemotherapy for advanced (metastatic) disease
- •Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
- •Previous treatment with any HER2-directed therapy, at any time, for any duration
- •Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
- •Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to peripheral bone metastases, if recovered from all toxicities)
- •History or evidence of brain metastases
- •Clinically significant active GI bleeding (Grade >/= 2 according to NCI-CTCAEv.4.03)
- •Other malignancy (in addition to GC) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
- •Inadequate hematologic, renal or liver function
- •Pregnant or lactating women
- •History of congestive heart failure of any New York Heart Association (NYHA) criteria
- •Angina pectoris requiring treatment
- •Myocardial infarction within the past 6 months before the first dose of study drug
- •Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
- •History or evidence of poorly controlled hypertension
- •Baseline left ventricular ejection fraction (LVEF) value < 55%
- •Any significant uncontrolled intercurrent systemic illness
- •Positive for hepatitis B, hepatitis C or HIV infection
结局指标
主要结局
-
efficacy Overall survival Time from randomization to death of any cause
次要结局
- Progression-free survival
- Overall objective response (partial response + complete response)
- Duration of objective response
- Clinical benefit rate
- Safety
研究者
研究点 (1)
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