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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Single-dose intravenous infusion administered on postoperative day 1.
Repeated intravenous infusions to reach equivalent total iron dose.
Hemoglobin response rate at 3 weeks post-treatment
Proportion of patients with hemoglobin increase ≥15g/L or absolute hemoglobin ≥110g/L at 3 weeks after study drug administration
Time frame: 3 weeks after treatment initiation
Proportion of participants meeting hemoglobin response criteria at postoperative Week 3
Hemoglobin response is defined as hemoglobin increased by ≥15 g/L from baseline (pre-medication on postoperative Day 1), OR absolute hemoglobin level ≥110 g/L at Week 3. Participants receiving allogeneic red blood cell transfusion will be excluded from response statistical analysis. Baseline hemoglobin value is collected before study drug administration on postoperative Day 1.
Time frame: Postoperative Week 3
Mean change in hemoglobin and hemoglobin normalization rate at postoperative Week 3 and Week 8
Mean ΔHb (hemoglobin difference vs baseline) at Week 3 and Week 8; Hb normalization standard: male ≥120 g/L, female ≥110 g/L.
Time frame: Postoperative Week 3, Postoperative Week 8
Changes in iron metabolism indicators and serum phosphorus at Week 3 and Week 8
Changes from baseline in serum ferritin, transferrin saturation and serum phosphorus at postoperative Week 3 and Week 8.
Time frame: Postoperative Week 3, Postoperative Week 8
Allogeneic blood transfusion demand within 8 weeks after radical gastrectomy
Transfusion proportion, average units of transfused red blood cells and total transfusion frequency of each participant from baseline to postoperative Week 8.
Time frame: Baseline to postoperative Week 8
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