Clinical Trial

Emotional Distress and Pathologic Response in Locally Advanced Gastric/GEJ Adenocarcinoma

Not Yet Recruiting
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Summary
This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.
Trial Details
NCT Number NCT07662070
Lead Sponsor West China Second University Hospital
Conditions Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Emotional Distress, Pathologic Response
Enrollment 120 participants
Start Date 2026-06-26
Primary Completion 2028-07-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-23