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ENROLLING BY INVITATION
NCT06923020

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

Sponsor: Yongxu Jia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-10-31

Completion Date

2027-10-31

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

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).

Locations (1)

Yongxu Jia

Zhengzhou, Henan, China