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NCT07772453 · ClinicalTrials.gov record · last posted 2026-08-19

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

Study acronym: IRIS
StatusNot Yet Recruiting
PhasePhase 4
Started2026-08
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07772453
Lead Sponsor Zhaojian Niu,MD
Conditions Gastric Cancer (GC), Iron Deficiency Anemia (IDA), Post-Operative Anemia, Radical Gastrectomy
Enrollment 160 participants
Start Date 2026-08
Primary Completion 2027-11 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-19