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

NCT06629714 | Completed

• 1 other identifier: 83242393
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Value of Neutrophils to lymphocytes ratio (NLR)

  0 day, 6 weeks

• Value of Platelet-lymphocyte ratio (PLR)

  0 day, 6 weeks

• Value of Monocyte-lymphocyte ratio (MLR)

  0 day, 6 weeks

• Value of Systemic immune inflammation index (SII)

  0 day, 6 weeks

• Value of Pan-immune inflammation value (PIV)

  0 day, 6 weeks

Other Outcomes (1)

• Prognostic models for immunotherapy

  0 day, 6 weeks

Study Arms (2)

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

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

Interventions

Exposure: emotional distress status OTHER

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 1: Treatment-naïve, advanced and inoperable GEC patients receiving first-line ICIs; Cohort 2: Treatment-naïve, advanced and inoperable NSCLC patients receiving first-line ICIs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Inflammation; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: October 16, 2020
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)