An observational study in Gastric Neoplasm and Esophageal Adenosquamous Carcinoma, sponsored by Yongxu Jia. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Yongxu Jia · Observational
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 200 is below the median of 281 across 684 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Yongxu Jia is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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metastatic ESCC and GC patients receiving the first-line therapy ICIs
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Exclusion Criteria:
advanced GC patients receiving first-line ICIs
Other: Exposure: Nutritional Status
advanced ESCC patients receiving first-line ICIs
Other: Exposure: Nutritional Status
The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA).
The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA).
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.
Time frame: 5 years
Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with EGC.
Time frame: 3 years
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 24 months is below that.
Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Yongxu Jia