NCT05967910 The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
| NCT ID | NCT05967910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Esophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05967910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05967910 currently recruiting?
Yes, NCT05967910 is actively recruiting participants. Contact the research team at wufang4461@csu.edu.cn for enrollment information.
Where is the NCT05967910 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05967910 clinical trial?
NCT05967910 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 200 participants.
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