A Retrospective Study for Evaluation of Real-world Efficacy and Safety of Ramucirumab Plus Paclitaxel in Patients With Locally-advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,063
- 试验地点
- 57
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review & Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.
详细描述
Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years at the time of study registration
- •Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- •Locally advanced unresectable or metastatic disease
- •Patients who have received previous palliative first-line systemic therapy including fluoropyrimidine and platinum for advanced gastric or gastroesophageal junction adenocarcinoma
- •Patients who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 under the Korea National Health Insurance System
排除标准
- •Patients who have received ramucirumab plus paclitaxel combination therapy outside of the Korea National Health Insurance System
- •Patients who have received ramucirumab monotherapy
结局指标
主要结局
Incidence of adverse events
时间窗: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
Overall survival
时间窗: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to death from any cause
Progression free survival
时间窗: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause
次要结局
- Objective response rate(Until September 30, 2019)
- Disease control rate(Until September 30, 2019)
- Adverse events of special interest(Until September 30, 2019)
- Time to progression(Until September 30, 2019)
- Duration of response(Until September 30, 2019)
研究者
Zang, Dae Young
Dae Young Zang MD, PhD
Hallym University Medical Center