About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 75 years, sex male or female, and body weight ≥ 50 kg.
Histopathologically confirmed gastric cancer (TNM stage I-III according to the AJCC 8th edition) and have undergone curative (R0) resection.
Postoperative anemia defined as a hemoglobin (Hb) level < 100 g/L within 24 hours after surgery (i.e., on postoperative day 1), meeting the diagnostic criteria for postoperative anemia in gastric cancer patients.
serum ferritin < 30 μg/L, or
Disqualifiers
Known hypersensitivity to ferric carboxymaltose, iron sucrose injection, or any of their excipients.
Evidence of iron overload (serum ferritin > 1000 μg/L) or a history of hemochromatosis.
ALT/AST > 2.5 × upper limit of normal (ULN),
serum creatinine > 1.5 × ULN,
Trial design
Treatments tested in this trial
- Ferric Carboxymaltose (FCM)
- Iron Sucrose.
Treatment groups
Locations
Sponsors and collaborators
Zhaojian Niu,MD
Lead sponsor
The Affiliated Hospital of Qingdao University
Sponsor institution