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

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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

NCT06629714•Anhui Medical University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort 1 \& 2
•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.

Locations (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

October 16, 2020

Primary Completion Date

April 20, 2025

Completion Date

April 20, 2025

Last Updated

January 13, 2026

Enrollment

196

ACTUAL participants

Conditions

Non Small Cell Lung CancerImmune Checkpoint InhibitorsInflammationCancer, Treatment-RelatedEmotional DistressGastroesophageal Cancer (GC)Biomarkers / BloodProgression-free Survival, PFS

Interventions

Exposure: emotional distress status

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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