Real-world Experience of Anti-PD-1 Immunotherapy Plus Chemotherapy as First-line Treatment for Patients With Advanced Oesophageal Squamous Cell Carcinoma in China(REACTION Trial).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,197
- 试验地点
- 23
- 主要终点
- OS from start of 1st line treatment in metastatic ESCC
研究概览
简要总结
This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.
详细描述
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with ICIs as 1st line treatment at approximately 26 institutions. The patients should have received at least 1 cycle of anti-PD-1 immunotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.
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
- •Age > 18, had an Eastern Cooperative Oncology Group performance status score of 0-3; Patients had unresectable or recurrent disease that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease; Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible); Patients accepted at least one cycle of anti-PD-1 immunotherapy as 1st line treatment, combined chemotherapy was allowed.
- •Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
排除标准
- •Patients who are prior exposure to immune-mediated therapy.
研究组 & 干预措施
ESCC patients treated with anti-PD-1 immunotherapy as 1st line treatment.
干预措施: Anti-PD-1 Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
OS from start of 1st line treatment in metastatic ESCC
时间窗: 2 years
Median OS and OS rate at 12 months, 18 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
次要结局
- the role of radiotherapy for patients treated with 1st immunotherapy.(2 years)
- PFS from start of 1st line treatment in metastatic ESCC(18 months)
研究者
Kuai Le Zhao, MD
Professor
Fudan University