Real-world Efficacy and Toxicity Data of the Combination of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
- •Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
- •Second-line treatment for advanced disease
- •Treatment for at least two months of second-line treatment.
排除标准
- •Lack of informed consent in case the patient was alive
研究组 & 干预措施
Patients who received paclitaxel - ramucirumab as second-line treatment
Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease with paclitaxel and ramucirumab, for at least two months.
干预措施: Paclitaxel and ramucirumab (Drug)
Patients who received other regimens as second-line treatment
patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines, except from paclitaxel and ramucirumab. All other regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment.
干预措施: Paclitaxel and ramucirumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years
The primary endpoint of interest was the assessment of progression-free survival (PFS1), defined as the time interval from the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, whichever occurred first.
次要结局
- Overall survival(From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years.)