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临床试验/NCT05543057
NCT05543057招募中不适用

Real-world Study on Comprehensive Treatment of Esophageal Cancer Based on Precision Radiotherapy

Zefen Xiao1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月1日最近更新:
适应症

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
1
主要终点
1-, 2-, 3-year overall survival

研究概览

简要总结

Radiotherapy is one of the main treatments for locally advanced esophageal carcinoma (EC). The accuracy of the existing imaging methods in diagnosing and predicting therapeutic efficacy is disappointing, which increases the difficulty in clinical decision-making. In this study, based on a continuous cohort of EC treated with radiotherapy, the clinical and pathological factors of the patients are used to classify them into the appropriate therapeutic group. By multiple liquid biopsy technologies, combining with radiomics, we intend to construct prediction models of prognosis, therapeutic effect and toxicity. The aim of this RWS is to provide appropriate individualized regimen, further optimize the treatment mode based on precision radiotherapy and improve the outcome and quality of life of EC patients.

详细描述

Radiotherapy is one of the main treatments for locally advanced esophageal squamous cell carcinoma (ESCC). The guidelines recommend neoadjuvant concurrent chemoradiotherapy plus surgery for resectable or potentially resectable patients; for unresectable patients, definitive chemoradiotherapy is the standard treatment. However, due to the complexity of the biological behavior of esophageal cancer (EC) and individual differences, fully complying with guideline recommendations in clinical practice is difficult and idealized. The results of prospective clinical trials are difficult to meet the demand of clinical diagnosis and treatment, thus, carrying out high-quality real-world study (RWS) is necessary.

Three-dimensional conformal radiotherapy (3DCRT) for unresectable EC yields 5-year OS rates of 34%-45.6%, which is an improvement over the rates reported in the RTOG 85-01 and 94-05 studies. Even so, there is still room for improvement of local control rate and overall survival. The accuracy of the existing imaging methods [computed tomography (CT), magnetic resonance imaging (MRI), endoscopic ultrasonography (EUS), endoscopic ultrasonography (EUS), as well as positron-emission tomography (PET)-CT, etc.] in diagnosing and predicting therapeutic efficacy is disappointing, which increases the difficulty in clinical decision-making. It is worthy to investigate an appropriate individualized radiation regimen based on different treatment sensitivity.

In this study, based on a continuous cohort of EC treated with radiotherapy, the clinical and pathological factors of the patients are used to classify them into the appropriate therapeutic group. Collect the blood and saliva samples before, during and after radiotherapy; the remaining diagnostic biopsy tissue samples. By using multiple liquid biopsy technologies [microbial flora, circulating tumor DNA (ctDNA), genome, RNA, and immunophenotype, ect.], combining with radiomics, construct prediction models of prognosis, therapeutic effect and toxicity. The aim of this RWS is to provide appropriate individualized regimen, further optimize the treatment mode based on precision radiotherapy and improve the outcome and quality of life of EC patients.

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

入选标准

  • Pathology proved esophageal cancer
  • ECOG PS ≤3
  • Signed Informed consent

排除标准

  • Pregnant and lactating women
  • Others that researchers consider inappropriate

结局指标

主要结局

1-, 2-, 3-year overall survival

时间窗: From treatment initiation to death from any cause or censor, assessed up to 36 months

Overall survival

次要结局

  • Quality of Life change, QoL(1/3/6/12/24 months after radiotherapy)
  • 1-, 2-, 3-year progression-free survival(From treatment initiation to first documented progression or death or censor, assessed up to 36 months)
  • Rate of acute toxicity (any and above grade 3)(From enrollment to 3 months after treatment)
  • Quality of life of patients with oesophageal cancer(1/3/6/12/24 months after radiotherapy)
  • Rate of acute/late toxicity (any and above grade 3)(After 3 months of enrollment)
  • 1-month short-term efficacy(Assessed 1-month after radiotherapy (short-term) according to RECIST 1.1)

研究者

发起方
Zefen Xiao
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

Zefen Xiao

Professor

Chinese Academy of Medical Sciences

研究点 (1)

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