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

A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Adenocarcinoma; Emotional Distress; Gastroesophageal Junction Adenocarcinoma; Pathologic Response
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Qing Li, PhD/MD; Phone Number: +8618702848178; Email: liqing@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with histologically confirmed, resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma who are planned to receive neoadjuvant/perioperative immunotherapy followed by curative-intent surgery at West China Hospital. Eligible participants must have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, no prior systemic antitumor treatment for the current tumor at baseline, and the ability to complete questionnaire assessments before and during treatment.

Description

Inclusion Criteria:

1. Willing to participate in this study.
2. Age >18 years; both sexes are eligible.
3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
4. Resectable locally advanced disease as assessed by imaging and/or multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.
5. Planned to receive neoadjuvant therapy followed by curative-intent surgery.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. No prior systemic antitumor treatment for the current tumor at baseline.
8. Able to understand and complete questionnaire assessments.
9. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.
2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.
3. Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.
4. Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.
5. Any other condition judged by the investigator to make the participant unsuitable for enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Not applicable- observational study; Not applicable- observational study
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.	Other: Not applicable- observational study; Not applicable- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major pathological response	Defined as 10% or less residual viable tumor cells in the resected primary tumor specimen after perioperative immunotherapy	Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all examined regional lymph nodes after completion of neoadjuvant immunotherapy and curative surgery.	Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy
Event-Free Survival (EFS)	Event-free survival is defined as the time from study enrollment to the first occurrence of any of the following events: disease progression during neoadjuvant treatment, failure to undergo curative surgery, postoperative recurrence, or death from any cause.	From enrollment up to 24 months
Overall Survival (OS)	Overall survival is defined as the time from study enrollment to death from any cause.	From enrollment up to 36 months

Collaborators and Investigators

• Sponsor: West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ED-GCGEJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No