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临床试验/NCT06490003
NCT06490003招募中不适用

Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2004年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Overall response rate(Chemotherapy)

研究概览

简要总结

Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

详细描述

Esophageal cancer remains a disease with a poor prognosis. In the treatment of esophageal squamous cell carcinoma (ESCC), multidisciplinary treatment including surgery, chemotherapy, and radiation therapy is important. Chemotherapy is an effective treatment for esophageal cancer, but some patients do not respond to it. Non-response to chemotherapy can result in disease progression, loss of patient fitness, and even the opportunity to receive other treatments that might have originally had a therapeutic effect. If there are biomarkers that could indicate the efficacy of chemotherapy before treatment, ineffective patients would be able to change their treatment plan. Patients on preoperative chemotherapy would be able to avoid unnecessary chemotherapy and undergo surgery without the effects of physical weakness and side effects. On the other hand, patients on definitive chemotherapy may choose to intensify their treatment with additional radiation therapy or immunotherapy. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients who had histologically confirmed esophageal squamous cell carcinoma.
  • Patients who had undergone chemotherapy.
  • Patients receiving initial chemotherapy
  • Written informed consent following full study information is provided to the patient.

排除标准

  • Patients for whom a preoperative biopsy sample cannot be obtained
  • Patients who cannot assess at 2 months later after chemotherapy.
  • Patients with multiple cancers.

研究组 & 干预措施

Chemotherapy non-response patients

Responders according to the response evaluation criteria in solid tumors (RECIST).

A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)

干预措施: Fluoro Uracil (Drug)

Chemotherapy response patients.

Responders according to the response evaluation criteria in solid tumors (RECIST).

A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)

干预措施: Fluoro Uracil (Drug)

结局指标

主要结局

Overall response rate(Chemotherapy)

时间窗: 1year

The effect of initial chemotherapy is evaluated by imaging. Response evaluation criteria in solid tumors (RECIST) is used for treatment efficacy.

次要结局

未报告次要终点

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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