跳至主要内容
临床试验/NCT05967910
NCT05967910招募中不适用

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

Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5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
200
试验地点
1
主要终点
Objective Response Rate (ORR)

研究概览

简要总结

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.

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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Objective Response Rate (ORR)

时间窗: 3 years

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Progression-free survival (PFS)

时间窗: 3 years

Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced esophageal cancer

Effect of Chronic stress on efficacy of immune checkpoint inhibitors

时间窗: 3 years

The chronic stress status including depression and anxiety symptoms.We will use two types of questionnaires, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), as a whole to conduct a comprehensive psychological assessment of patients. And then evaluate the impact of chronic stress status on the efficacy of immune checkpoint inhibitors, including ORR, PFS, and OS. PHQ-9 has 9 items, each on a scale of 0 to 3. The sum score (range 0 to 27) indicates the degree of depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderate to severe and severe levels of depression. GAD-7 has 7 items, each on a scale of 0 to 3. Higher total scores (ranging from 0 to 21) indicate higher anxious symptoms with 5 to 9 classified as mild, 10 to 14 classified as moderate, and 15 to 21 classified as moderate-severe.

次要结局

  • Overall survival (OS)(5 years)
  • Effect of chronic stress on quality of life(5 years)

研究者

发起方
Second Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Wu

chief physician

Second Xiangya Hospital of Central South University

研究点 (1)

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