Impact of chronic stress on immunotherapy effectiveness in esophageal cancer patients
The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
This study looks at how ongoing stress might affect the success of immune therapy in people with esophageal cancer who are just starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05967910 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how chronic stress affects the efficacy of immune checkpoint inhibitors (ICIs) in patients diagnosed with esophageal cancer. It aims to understand the relationship between psychological stress and tumor progression, particularly focusing on the hormonal responses triggered by stress. By analyzing tumor tissue samples and patient health indicators, the study seeks to clarify the potential impact of chronic stress on treatment outcomes for newly diagnosed patients who have not yet received systemic anti-tumor therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a pathologically confirmed diagnosis of esophageal cancer who have not yet received systemic treatment.
Not a fit: Patients with other concurrent malignancies or those with significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for esophageal cancer patients by addressing the role of stress in treatment efficacy.
How similar studies have performed: While there is evidence from animal models suggesting stress impacts tumor behavior, the specific effects on esophageal cancer and immunotherapy efficacy remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha, Hunan
- Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Fang Wu, MD.PhD
- Email: wufang4461@csu.edu.cn
- Phone: +86 135744858332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.