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NOT YET RECRUITING
NCT07772453
PHASE4

Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer

Sponsor: Zhaojian Niu,MD

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, randomized controlled trial. A total of 160 patients with iron-deficiency anemia after radical gastrectomy for gastric cancer will be enrolled and randomly assigned in a 1:1 ratio. Subjects in the experimental group will receive a single-dose intravenous ferric carboxymaltose on postoperative day 1, while the control group will receive multiple intravenous infusions of iron sucrose to achieve an identical total iron dose. All participants will follow standardized postoperative nutritional support and transfusion criteria. The primary endpoint is the hemoglobin response rate at postoperative week 3. Secondary endpoints include changes in hemoglobin and iron-related biomarkers, transfusion requirements, postoperative complications, functional recovery, and the incidence of adverse events. This study aims to compare the efficacy and safety of the two intravenous iron preparations and provide evidence for optimal postoperative iron supplementation for gastric cancer surgical patients.

Official title: Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer: A Multicenter Open-Label Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-08

Completion Date

2028-03

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DRUG

Ferric Carboxymaltose (FCM)

Single-dose intravenous infusion administered on postoperative day 1.

DRUG

Iron Sucrose.

Repeated intravenous infusions to reach equivalent total iron dose.