Comparison of the Prognosis and Safety of Different Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A National Multicenter Real-World Study(NEO-EC）
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 主要终点
- Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
研究概览
简要总结
The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China
详细描述
Neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy combined with surgery are the main treatment methods for patients with locally advanced esophageal squamous cell carcinoma, but some patients still have local recurrence or distant metastasis after surgery. In the era of immunotherapy, immune checkpoint inhibitor monotherapy or combined chemotherapy has become the first-line and second-line standard treatment for recurrent or metastatic esophageal cancer and has been recommended by NCCN guidelines. However, relevant studies on immunotherapy's participation in neoadjuvant therapy have shown good results, but it is still in its initial stage, and its efficacy needs further research and discussion.Thus, we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.
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 years, male or female;
- •KPS score (KPS) ≥70;
- •Esophageal squamous cell carcinoma confirmed by histopathology;
- •Clinical stage cT1b-4aN+M0,T3-4aN0M0;
- •Surgical resection was performed after 2~4 cycles of neoadjuvant therapy.
- •Expected survival > 6 months.
排除标准
- •Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
- •There are contraindications of immunotherapy or chemoradiotherapy;
- •Inability to tolerate or refuse surgery;
- •Distant metastasis has occurred;
结局指标
主要结局
Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
时间窗: 2015.1.1-2023.12.31
Pathological complete response (pCR) is defined as the absence of residual tumor cells after evaluation of removed tumor tissue and regional lymph nodes.
Comparison of major pathological response (MPR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
时间窗: 2015.1.1-2023.12.31
Major pathological response (MPR) is defined as a tumor that has significantly shrunk or decreased in the pathological evaluation, but still has a small number of residual tumor cells.
次要结局
- Comparison of the overall survival (OS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy(2015.1.1-2025.12.31)
- Comparison of the disease-free survival (DFS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy(2015.1.1-2025.12.31)