Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Histologically confirmed thoracic ESCC
- •Clinical stage cT1N+M0 or cT2-4aN0-3M0
- •Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy
排除标准
- •History of other malignancies
- •Did not complete neoadjuvant therapy or required salvage surgery
- •Incomplete baseline or follow-up data
研究组 & 干预措施
NICT group
干预措施: Neoadjuvant immunochemotherapy (Drug)
NCRT group
干预措施: Neoadjuvant Chemoradiotherapy (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 5 years
Time from first treatment to death from any cause or last follow-up.
Disease-Free Survival (DFS)
时间窗: 5 years
Time from surgery to recurrence, death, or last follow-up.
次要结局
- Pathological Complete Response (pCR) rate(3 months)
- Tumor Regression Grade (TRG)(3 months)
- R0 resection rate(3 months)
研究者
Yongtao Han
Chief Surgeon / Professor, Department of Thoracic Surgery
Sichuan Cancer Hospital and Research Institute
