Gastric Cancer (GC), Iron Deficiency Anemia (IDA), Post-Operative Anemia, Radical Gastrectomy
Conditions
Keywords
Ferric Carboxymaltose, Iron Sucrose, Intravenous Iron Supplementation, Gastrectomy, Postoperative Iron Deficiency, Gastric Cancer Surgery, Iron-deficiency Anemia
Brief 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.
Interventions
Single-dose intravenous infusion administered on postoperative day 1.
DRUGIron Sucrose.
Repeated intravenous infusions to reach equivalent total iron dose.
Sponsors
Zhaojian Niu,MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned into two parallel groups in a 1:1 ratio. One group receives single-dose ferric carboxymaltose, and the other group receives multiple infusions of iron sucrose with equivalent total iron dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Evidence of iron deficiency, as indicated by: * serum ferritin \< 30 μg/L, or * serum ferritin \< 100 μg/L and transferrin saturation (TSAT) \< 20%, confirming iron-deficiency anemia. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Adequate hepatic, renal, and coagulation function, defined as: * ALT and AST ≤ 2.5 × upper limit of normal (ULN), * serum creatinine ≤ 1.5 × ULN, * prothrombin time international normalized ratio (INR) ≤ 1.5. * Estimated life expectancy ≥ 3 months. * Voluntary written informed consent and ability to comply with the trial treatment and follow-up procedures.
Exclusion criteria
Non-iron-deficiency anemia (e.g., hemolytic anemia, thalassemia, megaloblastic anemia, aplastic anemia, tumor-related non-iron-deficiency anemia, etc.) or disorders of hemoglobin synthesis. * 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. * Severe hepatic or renal impairment, defined as: * ALT/AST \> 2.5 × upper limit of normal (ULN), * serum creatinine \> 1.5 × ULN, * or coagulopathy (INR \> 1.5); * or active bleeding (e.g., major postoperative anastomotic hemorrhage, intra-abdominal bleeding, etc.). * Receipt of oral iron, intravenous iron, or erythropoiesis-stimulating agents (ESAs) / erythropoietin (EPO) within the past 3 months prior to screening. * Concurrent other malignancies, severe cardiovascular disease (e.g., heart failure, history of myocardial infarction, severe arrhythmias), uncontrolled infectious disease (e.g., sepsis), or immunodeficiency disorders. * Pregnant or breastfeeding women, or women who plan to become pregnant during the trial period. * Inability to comply with the treatment and follow-up procedures (e.g., due to cognitive impairment, psychiatric disorders), or any other condition that, in the investigator's judgment, would render the participant unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin response rate at 3 weeks post-treatment | 3 weeks after treatment initiation | Proportion of patients with hemoglobin increase ≥15g/L or absolute hemoglobin ≥110g/L at 3 weeks after study drug administration |
| Proportion of participants meeting hemoglobin response criteria at postoperative Week 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in hemoglobin and hemoglobin normalization rate at postoperative Week 3 and Week 8 | Postoperative Week 3, Postoperative 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. |
| Changes in iron metabolism indicators and serum phosphorus at Week 3 and Week 8 | Postoperative Week 3, Postoperative Week 8 | Changes from baseline in serum ferritin, transferrin saturation and serum phosphorus at postoperative Week 3 and Week 8. |
| Allogeneic blood transfusion demand within 8 weeks after radical gastrectomy | Baseline to postoperative Week 8 | Transfusion proportion, average units of transfused red blood cells and total transfusion frequency of each participant from baseline to postoperative Week 8. |
Contacts
CONTACTZhaojian Niu, MD, PhD
PRINCIPAL_INVESTIGATORzhaojian Niu, MD, PhD
The Affiliated Hospital of Qingdao University
Outcome results
None listed