Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarkers / Blood | — | UNRESOLVED | — |
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
| Emotional Distress | — | UNRESOLVED | — |
| Gastroesophageal Cancer (GC) | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Progression-free Survival, PFS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exposure: emotional distress status | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Other: Exposure: emotional distress status
- label
- 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.
- interventionNames
- Other: Exposure: emotional distress status
Primary outcomes (1)
- measure
- Cohort 1 & 2: Progression-free survival (PFS)
- timeFrame
- 4 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available