Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and Lung Cancer Patients

Cohort Studies of Impact of Pretreatment Emotional on Survival and the Predictive Role of Peripheral Blood Metabolic and Inflammatory Markers in Immunotherapy Response Among Treatment-Naïve, Advanced and Inoperable Gastroesophageal and Non-Small-Cell Lung Cancer Patients

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).

Study Overview

• Status: Completed
• Conditions: Inflammation; Non Small Cell Lung Cancer; Emotional Distress; Cancer, Treatment-Related; Immune Checkpoint Inhibitors; Gastroesophageal Cancer (GC); Progression-free Survival, PFS; Biomarkers / Blood
• Intervention / Treatment: Other: Exposure: emotional distress status

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.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Second Affiliated hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cohort 1 comprises patients diagnosed with treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC), encompassing those with esophageal cancer, gastric cancer, and gastroesophageal junction cancer who are undergoing first-line ICI therapy. Cohort 2 consists of patients with treatment-naïve, advanced and inoperable Non-Small Cell Lung Cancer (NSCLC) receiving first-line ICI therapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs; For treatment-naïve, advanced and inoperable Esophageal Cancer or Gastric Cancer or Gastroesophageal junction (GEJ) Cancer patients who have received immune checkpoint inhibitors as first-line therapy.	Other: Exposure: 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.
Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs.; For treatment-naïve, advanced and inoperable Non-Small-Cell Lung Cancer patients who have received immune checkpoint inhibitors as first-line therapy.	Other: Exposure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1 & 2: Progression-free survival (PFS)	Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients	4 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of Neutrophils to lymphocytes ratio (NLR)	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.	0 day, 6 weeks
Value of Platelet-lymphocyte ratio (PLR)	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.	0 day, 6 weeks
Value of Monocyte-lymphocyte ratio (MLR)	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.	0 day, 6 weeks
Value of Systemic immune inflammation index (SII)	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.	0 day, 6 weeks
Value of Pan-immune inflammation value (PIV)	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.	0 day, 6 weeks
Value of eosinophil fraction	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.	0 day, 6 weeks
Value of prognostic nutritional index (PNI)	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.	0 day, 6 weeks
Value of Blood glucose	Blood glucose is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.	0 day, 6 weeks
Value of Triglycerides	Triglycerides is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.	0 day, 6 weeks
Value of Total cholesterol	Total cholesterol is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.	0 day, 6 weeks
Value of Albumin	Albumin is an indicator of metabolism in the body. The information has been extracted from the medical record and evaluated longitudinally.	0 day, 6 weeks
Disease Control Rate (DCR)	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).	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic models for immunotherapy	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.	0 day, 6 weeks

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): April 20, 2025
• Study Completion (Actual): April 20, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasms, Second Primary; Inflammation; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 83242393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No