Postoperative Recurrence Risk and Associated Factors in Patients With Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recurrence-Free Survival
研究概览
简要总结
This observational study aims to understand the risk of cancer returning after surgery in people with esophageal squamous cell carcinoma, a type of cancer of the food pipe. It focuses on people who received immunotherapy and chemotherapy before surgery.
Researchers will review existing medical records, scans, reports on tissue removed during surgery, and follow-up information. They will examine when and where cancer returns and which patient characteristics, treatment details, scan findings, and tissue findings are associated with its return.
All treatment and tests were part of routine care. The study does not assign treatment or require additional scans, tissue collection, or follow-up visits.
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 or older at the time of surgery.
- •Histologically confirmed esophageal squamous cell carcinoma.
- •Receipt of neoadjuvant immunochemotherapy, defined as an immune checkpoint inhibitor combined with chemotherapy, followed by curative esophagectomy between August 1, 2020, and October 31,
- •Microscopically negative surgical margins (R0 resection), postoperative M0 status confirmed on review using the American Joint Committee on Cancer eighth edition staging system, and verifiable postoperative ypT and ypN categories.
- •Availability of FDG PET/CT performed after completion of neoadjuvant treatment and before surgery, together with a verifiable surgery date, recurrence status, and valid follow-up dates. Availability of pretreatment PET/CT is not required.
排除标准
- •Histology other than esophageal squamous cell carcinoma, R1 or R2 resection.
- •Death within 30 days after surgery or absence of any verifiable postoperative outcome follow-up.
- •Missing essential pathological staging information, or survival data that prevent confirmation of eligibility or determination of the primary outcome despite review of source records. Missing nonessential variables alone will not result in exclusion.
研究组 & 干预措施
ESCC After Neoadjuvant Immunochemotherapy and Surgery
Patients with histologically confirmed esophageal squamous cell carcinoma who underwent curative esophagectomy between August 1, 2020, and October 31, 2025, after neoadjuvant immunochemotherapy. Existing clinical records, FDG PET/CT findings, surgical pathology reports, and postoperative follow-up records will be reviewed to assess recurrence risk and associated factors. All treatments and examinations were provided as part of routine clinical care and were not assigned by this study.
结局指标
主要结局
Recurrence-Free Survival
时间窗: From surgery through December 1, 2025, up to 64 months.
Time, in months, from surgery to the first documented local, regional, or distant recurrence, determined using imaging, pathology, or documented clinical assessment. Participants without recurrence will be censored at their last disease assessment. Death without documented recurrence is not an RFS event; these participants will be censored at their last disease assessment before death. RFS probabilities at 12 and 24 months after surgery will be estimated using the Kaplan-Meier method.
次要结局
未报告次要终点
研究者
Wu Nan
Professor
Peking University Cancer Hospital & Institute