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

NCT07772453 | Not Yet Recruiting Phase 4

• 1 other identifier: QYFYEC2026-107
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia (IDA); Post-Operative Anemia; Radical Gastrectomy; Gastric Cancer (GC)

Keywords

Ferric Carboxymaltose; Iron Sucrose; Intravenous Iron Supplementation; Gastrectomy; Postoperative Iron Deficiency; Gastric Cancer Surgery; Iron-deficiency Anemia

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Postoperative Week 3

Secondary Outcomes (3)

• Mean change in hemoglobin and hemoglobin normalization rate at postoperative Week 3 and Week 8

  Postoperative Week 3, Postoperative Week 8

• Changes in iron metabolism indicators and serum phosphorus at Week 3 and Week 8

  Postoperative Week 3, Postoperative Week 8

• Allogeneic blood transfusion demand within 8 weeks after radical gastrectomy

  Baseline to postoperative Week 8

Study Arms (2)

Ferric Carboxymaltose Group

EXPERIMENTAL

Patients receive single-dose intravenous ferric carboxymaltose on postoperative day 1 for iron-deficiency anemia after radical gastrectomy for gastric cancer.

Drug: Ferric Carboxymaltose (FCM)

Iron Sucrose Group

ACTIVE COMPARATOR

Patients receive multiple intravenous infusions of iron sucrose to achieve the same total iron dose for iron-deficiency anemia after radical gastrectomy for gastric cancer.

Drug: Iron Sucrose.

Interventions

Ferric Carboxymaltose (FCM) DRUG

Single-dose intravenous infusion administered on postoperative day 1.

Ferric Carboxymaltose Group

Iron Sucrose. DRUG

Repeated intravenous infusions to reach equivalent total iron dose.

Iron Sucrose Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhaojian Niu,MD: lead

MeSH Terms

Conditions

Stomach Neoplasms; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• zhaojian Niu, MD, PhD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaojian Niu, MD, PhD

CONTACT

+86-532-82911847; qdfynzj@qdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share