The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chronic psychological stress.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer, Immunotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
Overview
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.
Interventions
- Other chronic psychological stress
Chronic psychological stress includes symptoms of anxiety and depression.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: 3 years]
- Progression-free survival (PFS) [Time frame: 3 years]
- Effect of Chronic stress on efficacy of immune checkpoint inhibitors [Time frame: 3 years]
Secondary outcome measures (2)
- Overall survival (OS) [Time frame: 5 years]
- Effect of chronic stress on quality of life [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha
Identifiers
NCT: NCT05967910 · XYEYY2023052602