A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Safety as measured by number of participants with Grade 3 and 4 adverse events
研究概览
简要总结
The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Pathologically diagnosed as esophageal squamous cell carcinoma
- •Adequate organ function
- •No distant metastasis
- •The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist
排除标准
- •incomplete medical record which affects statistical analysis
- •have participated in previous interventional clinical trials
- •other situations evaluated by investigators not meet the enrollment
结局指标
主要结局
Safety as measured by number of participants with Grade 3 and 4 adverse events
时间窗: Up to 12 weeks
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Objective Response Rate (ORR)
时间窗: Up to 24 weeks
Objective Response Rate
Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
时间窗: Up to 36 weeks
The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.
次要结局
- Major pathological response(Three to five working days after surgery)
- R0 resection rate(Three to five working days after surgery)
- Pathologic complete response rate (pCR)(Three to five working days after surgery)
- Overall survival(from the date of diagnosis to the date of death, assessed up to 100 months)
- Event-free survival(from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months)