Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Fluoro Uracil
  Esophageal cancer chemotherapy（First line treatment)

Первичные конечные точки

• Overall response rate(Chemotherapy) [Срок оценки: 1year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Япония · 1 центр

• Yamanashi Universiy — Chūō

Публикации

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Идентификаторы

NCT: NCT06490003 · 23228/ESCC-Chemo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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