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In patients with advanced gastrointestinal cancers, malnutrition can lead to increased incidence of adverse events during the peri-chemoradiotherapy period, reduced treatment tolerance, lower completion rates of therapy, compromised efficacy and quality of life, and ultimately shortened survival. Currently, immunotherapy represented by PD-1 inhibitors has become a cornerstone in the treatment of advanced gastrointestinal cancers. Nutritional status plays a critical role in malignancies, with the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score being particularly important for assessing nutritional conditions in cancer patients. Gastrointestinal cancers, as a group of heterogeneous tumors with distinct morphological and molecular genetic features, are closely linked to nutritional status. Peripheral blood cell profiles reflect the inflammatory impact of malignancies and immune responses in patients, which are crucial for determining treatment responses and clinical outcomes to enable early stratification, intervention, and monitoring. Therefore, this study aims to explore the clinical significance of nutrition-related prognostic indicators in immunotherapy by evaluating nutritional status and comparing treatment efficacy of first-line immune checkpoint inhibitors among advanced gastric cancer and esophageal cancer patients (including unresectable locally advanced, recurrent, or metastatic gastrointestinal cancers such as gastric/gastroesophageal junction adenocarcinoma and esophageal carcinoma) with different nutritional profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | advanced GC patients receiving first-line ICIs |
| |
| Cohort B | advanced ESCC patients receiving first-line ICIs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: Nutritional Status | Other | The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with EGC. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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metastatic ESCC and GC patients receiving the first-line therapy ICIs
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongxu Jia | Zhengzhou | Henan | 450000 | China |
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| Exposure: Nutritional Status | Other | The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA). |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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