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

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; Immune Checkpoint Inhibitors; Inflammation; Cancer, Treatment-Related; Emotional Distress; Gastroesophageal Cancer (GC); Biomarkers / Blood; Progression-free Survival, PFS

• Registration Number: NCT06629714

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.

Study Timeline

• Study Start: 2020-10-16
• Status Verified: 2024-07
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-10-16
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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).

Trial Locations

Locations (1)

Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China