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

NCT07662070 | Not Yet Recruiting

• 1 other identifier: ED-GCGEJ
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pathological Complete Response (pCR)

  Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy

• Event-Free Survival (EFS)

  From enrollment up to 24 months

• Overall Survival (OS)

  From enrollment up to 36 months

Study Arms (2)

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

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

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

No Pretreatment Emotional Distress; Pretreatment Emotional Distress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing to participate in this study.
• Age \>18 years; both sexes are eligible.
• Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
• 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.
• Planned to receive neoadjuvant therapy followed by curative-intent surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• No prior systemic antitumor treatment for the current tumor at baseline.
• Able to understand and complete questionnaire assessments.
• Able and willing to provide written informed consent.

You may not qualify if:

• Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.
• Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.
• Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.
• 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.
• Any other condition judged by the investigator to make the participant unsuitable for enrollment.

Sponsors & Collaborators

• West China Second University Hospital: lead

Central Study Contacts

Qing Li, PhD/MD

CONTACT

+8618702848178; liqing@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD/MD

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share