The Effect of Chronic Stress on Efficacy of ICIs in Ⅲ-Ⅳ Lung Cancer Patients
Study Details
Study Description
Brief Summary
Chronic stress is the response of the body to physiological and psychological stressors and manifests as depression and anxiety symptoms, which are common among cancer patients. It was reported that chronic stress could contribute to a highly immunosuppressive tumor microenvironment and undermine the efficacy of immune checkpoint inhibitors (ICIs) in preclinical studies. Therefore, we investigate the impact of chronic stress on the efficacy of ICIs among lung cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lung patients recieve first-line immunotherapy For stage III-IV patients with lung cancer who have received immune checkpoint inhibitors as first-line therapy. |
Other: Gut microbiota detection
The baseline fetal is collected and assessed by 16S rRNA sequencing
Other: Peripheral immune cells signature detaction
The baseline peripheral venous blood is collected and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells
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Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [2 years]
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Progression-free survival (PFS) [3 years]
Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced NSCLC
- Effect of Chronic stress on efficacy of immune checkpoint inhibitors [3 years]
The chronic stress status including depression and anxiety symptoms were assessed by Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaire respectively. And then evaluate the impact of chronic 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.
Secondary Outcome Measures
- Overall survival (OS) [5 years]
Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
- Effect of chronic stress on quality of life [5 years]
Chronic stress status including depression and anxiety symptoms. Quality of life (QoL) is assessed longitude by Short Form Health Survey 36 (SF-36) and EORTC QLQ-C30 (version.3). SF-36 includes 36 items and assesses the functional status and well-being on eight multi-item subscales. The total score on each SF-36 subscale ranges between 0 and 100. A greater score indicates better QoL. The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.
Other Outcome Measures
- The correlation between gut microbiota and chronic stress and the efficacy of ICIs [5 years]
The baseline fetal is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress and the efficacy of ICIs during the enrolled observation process.
- The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs [5 years]
The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and chronic stress and the efficacy of ICIs during the enrolled observation process.
- The correlation between peripheral immune cells signature and chronic stress and the efficacy of ICIs [5 years]
The baseline peripheral venous blood is collected and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between peripheral immune cells signature signature and chronic stress and the efficacy of ICIs during the enrolled observation process.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years;
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Newly diagnosed Stage III-IV lung cancer diagnosed pathologically based on Lung Cancer AJCC v8;
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At least one measurable lesion can be evaluated according to RECIST v1.1;
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Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy ).
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Expected immune checkpoint inhibitors or immunotherapy combined with chemotherapy as first-line treatments;
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There was no obvious abnormality in ECG and cardiac dysfunction;
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Hematology, liver, and kidney function indicators meet the requirements
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Informed and agreed to participate in the study
Exclusion Criteria:
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Combined with other malignant tumors in the past 3 years and other malignant diseases requiring systematic treatment;
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Complicated with acute or chronic mental illness;
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long-term administration of glucocorticoid;
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Patients who had received other clinical drug experiments;
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Patients with symptomatic brain metastasis;
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Can't cooperate with psychological scale assessment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Oncology, The Second Xiangya Hospital, Central South University | Changsha | Hunan | China | 410011 |
Sponsors and Collaborators
- Second Xiangya Hospital of Central South University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XYEYY20220704