The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)

Официальное название

The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer

Обзор

Chronic stress refers to a special emotional state caused by unexpected stress for a long time, with an increasing incidence in the population. It can cause the body to release hormones such as cortisol and adrenaline. Tumor patients often experience changes such as psychological and emotional abnormalities, decreased quality of life, and impaired social relationships. Under stimulation, patients often experience negative reactions such as anxiety or depression. Epidemiological studies have shown that stress can affect the prognosis of malignant tumors, but the effect of stress on the efficacy and prognosis of esophageal cancer is still unclear. In animal models, chronic stress leads to an increase in tissue catecholamine levels, increased tumor burden, and increased invasiveness of ovarian cancer cells in mouse models. At the same time, stress can promote tumor neovascularization in mice. However, the mechanism by which chronic stress affects the occurrence and development of esophageal cancer is currently unclear. In addition to neurohumoral factors, chronic stress can cause changes in the gut microbiota, which in turn affects the body's digestion, metabolism, and immune function. It is a key gatekeeper of the immune response to tumors. Therefore, gut microbiota as an intermediate factor may also affect the occurrence and prognosis of various types of esophageal cancer.

Вмешательства

• Другое chronic psychological stress
  Chronic psychological stress includes symptoms of anxiety and depression.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 3 years]
• Progression-free survival (PFS) [Срок оценки: 3 years]
• Effect of Chronic stress on efficacy of immune checkpoint inhibitors [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Overall survival (OS) [Срок оценки: 5 years]
• Effect of chronic stress on quality of life [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥18 years and ≤ 75 years old
• Pathologically diagnosed as esophageal cancer
• Patient tumor tissue samples can be obtained
• At least one measurable lesion can be evaluated according to the RECIST 1.1 standard
• As a newly treated patient, they have not received systematic anti-tumor treatment for locally advanced or metastatic chest tumors
• There is no obvious abnormality in the electrocardiogram and no obvious cardiac dysfunction
• Hematology and liver and kidney function indicators meet the requirements

Критерии исключения

• Merge with other malignant tumors
• Long term use of hormones or immunosuppressants
• Concomitant acute or chronic mental illness
• Patients who have been taking drugs that can alter the activity of the sympathetic nervous system for a long time or are currently taking them
• Other malignant diseases that require systematic treatment
• Patients who have undergone other clinical drug experiments before
• Patients with symptomatic brain metastases

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Oncology, The Second Xiangya Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT05967910 · XYEYY2023052602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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