Status:
RECRUITING
The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
Lead Sponsor:
Second Xiangya Hospital of Central South University
Collaborating Sponsors:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha Central Hospital
Conditions:
Esophageal Cancer
Immunotherapy
Eligibility:
All Genders
18-75 years
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 cortis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05967910
Start Date
May 1 2023
End Date
December 31 2026
Last Update
January 23 2024
Active Locations (1)
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1
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011