JPRN-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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 780
研究概览
简要总结
Adding pertuzumab to trastuzumab and chemotherapy did not significantly improve overall survival in patients with HER2-positive metastatic gastric or gastro-oesophageal junction cancer compared with placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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
研究者
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