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

ConditionsGastric Cancer (GC)Iron Deficiency Anemia (IDA)Post-Operative AnemiaRadical Gastrectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhaojian Niu,MD

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ferric Carboxymaltose (FCM)

    Drug

    Single-dose intravenous infusion administered on postoperative day 1.

  • Iron Sucrose.

    Drug

    Repeated intravenous infusions to reach equivalent total iron dose.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Ferric Carboxymaltose GroupExperimental treatment 1 intervention
Group B: Iron Sucrose GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhaojian Niu,MD

Lead sponsor

The Affiliated Hospital of Qingdao University

Sponsor institution

Source ClinicalTrials.gov

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