Emotional Distress, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Pathologic Response
Conditions
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.
Interventions
OTHERNot applicable- observational study
Not applicable- observational study
Sponsors
West China Second University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major pathological response | Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation | Defined as 10% or less residual viable tumor cells in the resected primary tumor specimen after perioperative immunotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy | 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. |
| Event-Free Survival (EFS) | From enrollment up to 24 months | 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. |
| Overall Survival (OS) | From enrollment up to 36 months | Overall survival is defined as the time from study enrollment to death from any cause. |
Contacts
CONTACTQing Li, PhD/MD
Outcome results
None listed