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

Sponsor
West China Second University Hospital
Study ID
NCT07662070
Status
Not Yet Recruiting

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Conditions

  • Emotional Distress
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Pathologic Response

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Not applicable- observational study — OTHER
    Not applicable- observational study

Study Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Jun 26, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Pretreatment Emotional Distress
    Participants with pretreatment emotional distress, defined as a PHQ-9 score of 5 or higher and/or a GAD-7 score of 5 or higher before initiation of perioperative immunotherapy. These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan. This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.
  • Arm: No Pretreatment Emotional Distress
    Participants without pretreatment emotional distress, defined as a PHQ-9 score lower than 5 and a GAD-7 score lower than 5 before initiation of perioperative immunotherapy. These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan. This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.

Primary Outcome Measure

major pathological response [ Time Frame: Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation ]

Central Contacts

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