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临床试验/NCT07236320
NCT07236320已完成不适用

Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study

Yongtao Han1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年3月1日最近更新:
干预措施

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

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

Experimental

干预措施: Neoadjuvant immunochemotherapy (Drug)

NCRT group

Active Comparator

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

发起方
Yongtao Han
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yongtao Han

Chief Surgeon / Professor, Department of Thoracic Surgery

Sichuan Cancer Hospital and Research Institute

研究点 (1)

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