NCT06923020

Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric Cancer.

Exploring the Correlation Between Nutritional Status and Efficacy of First-Line Immune Checkpoint Inhibitors in Metastatic Esophagogastric Cancer: A Prospective Cohort Study.(Nutrition EGC)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Yongxu Jia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Neoplasm
• Esophageal Adenosquamous Carcinoma

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-04-11
• Last updated: 2025-04-11

Locations

1 site across 1 country: China