Biomarkers / Blood, Cancer, Treatment-Related, Emotional Distress, Gastroesophageal Cancer (GC), Immune Checkpoint Inhibitors, Inflammation, Non Small Cell Lung Cancer, Progression-free Survival, PFS
Conditions
Brief summary
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).
Detailed description
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts: * Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients. * Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.
Interventions
OTHERExposure: emotional distress status
The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a sum score of PHQ-9 and GAD-7 ≥ 10 were categorized as the stressed group.
Sponsors
Anhui Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 & 2 Inclusion Criteria: * Meet the diagnostic criteria for cancer (including esophageal, gastric, GEJ or NSCLC) through clinical, pathological, and imaging examinations; * Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points; * Unresectable locally advanced or metastatic; * Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy); * Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1); * Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; * Informed and agreed to participate in the study; * Required to complete the questionnaire independently or with assistance from others if needed; * Legal age, 18 years or older.
Exclusion criteria
* Oncogene-driver positive; * Combined with other malignant tumors in the past 3 years; * Concurrent acute or chronic psychiatric disorders; * Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs; * Previous treatment with other clinical drug trials; * Patients with symptomatic brain metastasis; * Severe intellectual disabilities or other communication difficulties that hindered normal interaction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 & 2: Progression-free survival (PFS) | 4 year | Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Value of Pan-immune inflammation value (PIV) | 0 day, 6 weeks | PIV is an inflammatory indicator, which is equal to neutrophils × monocytes × platelets/lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of eosinophil fraction | 0 day, 6 weeks | The eosinophil fraction is a potential inflammation and tumor prognostic indicator, which equals the ratio of eosinophil absolute value to the total white blood cell count. The higher the value of this fraction, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of prognostic nutritional index (PNI) | 0 day, 6 weeks | PNI is a potential inflammation and tumor prognostic indicator, which is equal to albumin level (g/L) + 5 × absolute value of lymphocyte counts. The higher the value of this index, the better the tumor prognosis may be. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Neutrophils to lymphocytes ratio (NLR) | 0 day, 6 weeks | NLR is an inflammatory marker, which is the ratio of neutrophils to lymphocytes. The higher the value is, the higher the inflammatory level may be. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Platelet-lymphocyte ratio (PLR) | 0 day, 6 weeks | PLR is an inflammatory marker, a ratio of platelets to lymphocytes. A higher value of it indicates a higher level of inflammation in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Monocyte-lymphocyte ratio (MLR) | 0 day, 6 weeks | MLR is an inflammatory indicator, which is the ratio of macrophages and lymphocytes. The higher the value is, the higher the inflammatory level in the body is. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Blood glucose | 0 day, 6 weeks | Blood glucose is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Triglycerides | 0 day, 6 weeks | Triglycerides is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Total cholesterol | 0 day, 6 weeks | Total cholesterol is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| Value of Albumin | 0 day, 6 weeks | Albumin is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally. |
| Disease Control Rate (DCR) | 1 year | DCR refers to the proportion of patients with tumor treated with a certain treatment who have tumor shrinkage or stable disease, and this state can be maintained for a certain period of time, including the proportion of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). |
| Value of Systemic immune inflammation index (SII) | 0 day, 6 weeks | SII is an inflammatory indicator, which is calculated as follows: SII= (neutrophil × platelet)/lymphocytes. A higher value indicates an elevated level of inflammation within the body. The information has been extracted from the medical record and evaluated longitudinally. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prognostic models for immunotherapy | 0 day, 6 weeks | Tumor biomarkers, such as CEA, CA19-9, CA72-4, NSE, SCC, and the above-mentioned metabolic and inflammatory markers in peripheral blood were collected at baseline and after two cycles of treatment (6 weeks). The scores of PHQ-9 and GAD-7 questionnaires were also collected. The variables were screened to establish an optimal prognostic model. |
Countries
China
Outcome results
None listed