TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The Incidence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
To confirm the safety and efficacy of this drug under the actual use
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug*
- •Patients who receive this drug* for the first time after this drug* is launched * Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug
排除标准
- •- not specified in this study
研究组 & 干预措施
TRASTUZUMAB BS
Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS
干预措施: TRASTUZUMAB BS (Drug)
结局指标
主要结局
The Incidence of Adverse Drug Reactions (ADRs)
时间窗: From Day 1 to 28 days after the last dose within 24 weeks; to the first dose after 24 weeks; or to the next treatment. If discontinued before 24 weeks, it was until 28 days after discontinuation or until the next treatment. Maximum duration was 28 weeks.
An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to TRASTUZUMAB BS for Intravenous Infusion 60mg \[Pfizer\] and/or 150mg \[Pfizer\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to this drug was assessed.
次要结局
- Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1(From Day 1 to 28 days after the last dose within 24 weeks from Day 1; to the first dose after 24 weeks; or to the next treatment. If discontinued, it ends at the time of discontinuation. Maximum duration was 28 weeks.)