NCT06602843招募中不适用
Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75;
- •Radical operation for esophageal cancer;
- •Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
- •More than or equal to 12 lymph nodes were surgically removed;
- •Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
- •Informed consent signed by patient or family member.
排除标准
- •Less than 18 years old, more than 75 years old;
- •did not receive radical resection of esophageal cancer, including palliative resection;
- •Postoperative pathology showed non-esophageal squamous cell carcinoma;
- •After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
- •Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
- •The patient or family member did not sign the informed consent.
结局指标
主要结局
pCR
时间窗: immediately after the intervention/procedure/surgery
Pathologic Complete Response
次要结局
- R0 resection rate(immediately after the intervention/procedure/surgery)
研究者
研究点 (1)
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