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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Not applicable- observational study |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Li, PhD/MD | Contact | +8618702848178 | liqing@scu.edu.cn |
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| 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 |