Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poor Objective Sleep Characteristics Group | Participants whose objective sleep characteristics during neoadjuvant immunotherapy are below the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having poor objective sleep characteristics for observational analysis only. |
| |
| Favorable Objective Sleep Characteristics Group | Participants whose objective sleep characteristics during neoadjuvant immunotherapy are at or above the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having favorable objective sleep characteristics for observational analysis only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Not applicable- observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) | The proportion of participants who achieve major pathological response after neoadjuvant immunotherapy. MPR is defined as residual viable tumor cells of 10% or less in the resected tumor specimen after radical surgery. | From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | The proportion of participants who achieve pathological complete response after neoadjuvant immunotherapy. pCR is defined as the absence of residual viable tumor cells in the resected primary tumor specimen and, if applicable, resected lymph nodes after radical surgery. | From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.
Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:
Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
Not provided
Not provided
Not provided
Adult patients with histologically confirmed locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are assessed as resectable by imaging or a multidisciplinary team and are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Eligible participants should have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, and no prior systemic anticancer therapy for the current tumor at study baseline.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Li, PhD/MD | Contact | +8618702848178 | liqing@scu.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| R0 Resection Rate | The proportion of participants who undergo radical surgery with microscopically margin-negative resection. R0 resection is defined as no residual tumor at the surgical resection margins based on postoperative pathological assessment. | From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months. |
| Event-Free Survival (EFS) | EFS is defined as the time from enrollment to the first occurrence of any event, including disease progression that precludes radical surgery, local or distant recurrence, or death from any cause, whichever occurs first. | From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months. |
| Recurrence-Free Survival (RFS) | RFS is defined as the time from radical surgery to the first documented local or distant recurrence, or death from any cause, whichever occurs first. Participants without recurrence or death will be censored at the date of last follow-up. | From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months. |
| Overall Survival (OS) | OS is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date of last follow-up. | From enrollment to death or last follow-up, assessed up to approximately 30 months. |