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

Anhui Medical University

Status: Completed

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

Treatments: Other: Exposure: emotional distress status

Study type: Observational

Funder types: Other

Identifiers

NCT06629714

83242393

Details and patient eligibility

About

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).

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

196 participants in 2 patient groups

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

Description:

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.

Treatment:

Other: Exposure: emotional distress status

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

Description:

For treatment-naïve, advanced and inoperable Non-Small-Cell Lung Cancer patients who have received immune checkpoint inhibitors as first-line therapy.

Treatment:

Other: Exposure: emotional distress status