Real-world Experience of Immunotherapy Plus Chemotherapy as First-line Treatment With or Without Radiotherapy for Patients With Advanced Oesophageal Squamous Cell Carcinoma in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 728
- 试验地点
- 5
- 主要终点
- PFS
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 chemotherapy combined with immunotherapy as 1st line treatment at approximately 5 institutions. The patients should have received at least 1 cycle of immunotherapy and chemotherapy 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 90 Years（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;
- •The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
- •Patients had received no previous systemic therapy
- •Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
- •Complete medical records;
排除标准
- •Surgery for esophageal cancer;
- •Esophageal fistulae due to infiltration of the primary tumour.
- •Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
- •Those who have a history of autoimmune disease or have been treated with immunosuppressants within the last 3 months.
- •Those who have received organ transplant surgery.
- •Patients with a previous history of malignant tumor (skin basal cell carcinoma and cervical carcinoma in situ) survived tumor-free for 3 years after treatment.
- •Except for the above).
- •There are other serious diseases, such as myocardial infarction, cerebral infarction or severe cardiopulmonary insufficiency within 6 months
研究组 & 干预措施
Arm A
Chemotherapy combined with immunotherapy group
干预措施: Chemotherapy combined with immunotherapy (Drug)
Arm B
Chemotherapy combined with immunotherapy + radiotherapy group
干预措施: Chemotherapy combined with immunotherapy (Drug)
Arm B
Chemotherapy combined with immunotherapy + radiotherapy group
干预措施: radiotherapy (Radiation)
结局指标
主要结局
PFS
时间窗: up to 2 years
progression-free survival
次要结局
- ORR(up to 2 years)
- RP(up to 2 years)
- OS(up to 2 years)
- DoR(up to 2 years)