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临床试验/NCT05615103
NCT05615103招募中不适用

The Efficiency of 18F-FDG PET-CT for Predicting Advanced Oesophageal Squamous Cell Carcinoma Patients' Tumor Response to Immunochemotherapy in the Neoadjuvant Setting

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Pathologic complete response rate (pCR)

研究概览

简要总结

Treatment with immune checkpoint inhibitors such as programmed death receptor 1 (PD-1 inhibitors) for advanced and metastatic esophageal squamous cell carcinoma (ESCC) significantly improves patients' overall survival compared to chemotherapy alone. Despite this milestone breakthrough, immunochemotherapy also has known limitations. Indeed, only 45-72% of patients achieved objective responses. It is urgent to find out easily-determined and convenient biomarkers to identify patients who will benefit from such treatment modality. Due to the luminal structure of the esophagus, the exact diameter of esophageal tumor cannot be precisely measured per RECIST 1.1. Moreover, the definition of the metastatic lymph node in which the short-axis lengths should be longer than 1.5 cm hinders the risk of missing the smaller metastatic lymph node foci. Thus, it is difficult to implement morphology-based criteria for evaluating the neoadjuvant immunochemotherapy response. The current study aimed to investigate the role of iPERCIST in predicting tumor response and the short-term overall survival of patients with locally advanced ESCC after neoadjuvant immunochemotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy.
  • treatment-naïve and had the adequate cardiopulmonary function

排除标准

  • previous autoimmune disease
  • unable to complete planned treatment courses and no complete follow-up PET-CT scan

结局指标

主要结局

Pathologic complete response rate (pCR)

时间窗: Three to five working days after surgery

The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

次要结局

  • Safety as measured by number of participants with Grade 3 and 4 adverse events(Up to 12 weeks)
  • Event-free survival(from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months)
  • Overall survival(from the date of diagnosis to the date of death, assessed up to 100 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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