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NCT Number: NCT06629714

Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and 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).

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Key information

Conditions

Non Small Cell Lung Cancer Biomarkers / Blood Bronchial Neoplasms Cancer, Treatment-Related Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Emotional Distress Gastroesophageal Cancer (GC) Immune Checkpoint Inhibitors Inflammation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neoplasms, Second Primary Pathologic Processes Pathological Conditions, Signs and Symptoms Progression-free Survival, PFS Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cohort 1 & 2: Progression-free survival (PFS)

    Time frame: 4 year

    Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients

Secondary outcomes

  1. Value of Neutrophils to lymphocytes ratio (NLR)

    Time frame: 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.

  2. Value of Platelet-lymphocyte ratio (PLR)

    Time frame: 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.

  3. Value of Monocyte-lymphocyte ratio (MLR)

    Time frame: 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.

  4. Value of Systemic immune inflammation index (SII)

    Time frame: 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.

  5. Value of Pan-immune inflammation value (PIV)

    Time frame: 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.

  6. Value of eosinophil fraction

    Time frame: 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.

  7. Value of prognostic nutritional index (PNI)

    Time frame: 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.

  8. Value of Blood glucose

    Time frame: 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.

  9. Value of Triglycerides

    Time frame: 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.

  10. Value of Total cholesterol

    Time frame: 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.

  11. Value of Albumin

    Time frame: 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.

  12. Disease Control Rate (DCR)

    Time frame: 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).

Other outcomes

  1. Prognostic models for immunotherapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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