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

NCT05967910 | Recruiting

• 1 other identifier: XYEYY2023052602
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  3 years

• Progression-free survival (PFS)

  Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced esophageal cancer

  3 years

• Effect of Chronic stress on efficacy of immune checkpoint inhibitors

  The chronic stress status including depression and anxiety symptoms.We will use two types of questionnaires, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), as a whole to conduct a comprehensive psychological assessment of patients. And then evaluate the impact of chronic stress status on the efficacy of immune checkpoint inhibitors, including ORR, PFS, and OS. PHQ-9 has 9 items, each on a scale of 0 to 3. The sum score (range 0 to 27) indicates the degree of depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderate to severe and severe levels of depression. GAD-7 has 7 items, each on a scale of 0 to 3. Higher total scores (ranging from 0 to 21) indicate higher anxious symptoms with 5 to 9 classified as mild, 10 to 14 classified as moderate, and 15 to 21 classified as moderate-severe.

  3 years

Secondary Outcomes (2)

• Overall survival (OS)

  5 years

• Effect of chronic stress on quality of life

  5 years

Other Outcomes (3)

• The correlation between gut microbiota and chronic stress and the efficacy of ICIs

  5 years

• The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs

  5 years

• The correlation between peripheral immune cells signature and chronic stress and the efficacy of ICIs

  5 years

Study Arms (4)

Early esophageal cancer patients with chronic psychological stress

Other: chronic psychological stress

Early esophageal cancer patients without chronic psychological stress

Advanced esophageal cancer patients with chronic psychological stress

Other: chronic psychological stress

Advanced esophageal cancer patients without chronic psychological stress

Interventions

chronic psychological stress OTHER

Chronic psychological stress includes symptoms of anxiety and depression.

Advanced esophageal cancer patients with chronic psychological stress; Early esophageal cancer patients with chronic psychological stress

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 cases of esophageal cancer patient are required and is divided into two groups: the experimental group (stress group) and the control group (non stress group) within each early and late stage group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator
• Changsha Central Hospital: collaborator

Study Sites (1)

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Fang Wu, MD.PhD

CONTACT

+86 135744858332; wufang4461@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)