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临床试验/NCT06889402
NCT06889402尚未招募不适用

Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy:A Multicenter Study

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
试验地点
1
主要终点
Disease-Free Survival

研究概览

简要总结

Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
  • Patients with thoracic esophageal squamous cell carcinoma
  • The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
  • Patients with complete pathological response (ypT0N0M0)
  • Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs

排除标准

  • Patients with previous history of malignant tumors
  • Patients with multiple primary cancers
  • Deficient neoadjuvant treatment or salvage surgery
  • Incomplete clinical data

结局指标

主要结局

Disease-Free Survival

时间窗: The postoperative follow-up period should last for at least one year.

The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.

次要结局

  • Overall Survival Rate(The postoperative follow-up period should last for at least one year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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