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

Central South University

Status: Enrolling

Conditions: Esophageal Cancer; Immunotherapy

Treatments: Other: chronic psychological stress

Study type: Observational

Funder types: Other

Identifiers

NCT05967910

XYEYY2023052602

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Early esophageal cancer patients with chronic psychological stress

Treatment:

Other: chronic psychological stress

Early esophageal cancer patients without chronic psychological stress

Advanced esophageal cancer patients with chronic psychological stress

Treatment:

Other: chronic psychological stress

Advanced esophageal cancer patients without chronic psychological stress