Clinical trial NCT05967910: The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
Official title: The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Immunotherapy
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Changsha Central Hospital
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 cases of esophageal cancer patient are required and is divided into two groups: the experimental group (stress group) and the control group (non stress group) within each early and late stage group.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Merge with other malignant tumors
2. Long term use of hormones or immunosuppressants
3. Concomitant acute or chronic mental illness
4. 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
5. Other malignant diseases that require systematic treatment
6. Patients who have undergone other clinical drug experiments before
7. Patients with symptomatic brain metastases

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 years
measure: Progression-free survival (PFS)
timeFrame: 3 years
measure: Effect of Chronic stress on efficacy of immune checkpoint inhibitors
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Effect of chronic stress on quality of life
timeFrame: 5 years
Other outcomes:
measure: The correlation between gut microbiota and chronic stress and the efficacy of ICIs
timeFrame: 5 years
measure: The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs
timeFrame: 5 years
measure: The correlation between peripheral immune cells signature and chronic stress and the efficacy of ICIs
timeFrame: 5 years
Locations:
city: Changsha
country: China
facility: Department of Oncology, The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: