Clinical trial NCT06629714: Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and Lung Cancer Patients
Official 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
Study type: OBSERVATIONAL
Overall status: 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
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 1 & 2: Progression-free survival (PFS)
timeFrame: 4 year
Secondary outcomes:
measure: Value of Neutrophils to lymphocytes ratio (NLR)
timeFrame: 0 day, 6 weeks
measure: Value of Platelet-lymphocyte ratio (PLR)
timeFrame: 0 day, 6 weeks
measure: Value of Monocyte-lymphocyte ratio (MLR)
timeFrame: 0 day, 6 weeks
measure: Value of Systemic immune inflammation index (SII)
timeFrame: 0 day, 6 weeks
measure: Value of Pan-immune inflammation value (PIV)
timeFrame: 0 day, 6 weeks
measure: Value of eosinophil fraction
timeFrame: 0 day, 6 weeks
measure: Value of prognostic nutritional index (PNI)
timeFrame: 0 day, 6 weeks
measure: Value of Blood glucose
timeFrame: 0 day, 6 weeks
measure: Value of Triglycerides
timeFrame: 0 day, 6 weeks
measure: Value of Total cholesterol
timeFrame: 0 day, 6 weeks
measure: Value of Albumin
timeFrame: 0 day, 6 weeks
measure: Disease Control Rate (DCR)
timeFrame: 1 year
Other outcomes:
measure: Prognostic models for immunotherapy
timeFrame: 0 day, 6 weeks
Locations:
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: