Gastric Cancer (GC)Phase 4IRISNCT07772453
Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer
A Phase 4 study testing Ferric Carboxymaltose (FCM) and Iron Sucrose. in people with Gastric Cancer (GC) and Iron Deficiency Anemia (IDA), run by Zhaojian Niu,MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC), Iron Deficiency Anemia (IDA), Post-Operative Anemia
- What is being tested?
- Ferric Carboxymaltose (FCM) and Iron Sucrose.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer: A Multicenter Open-Label Randomized Controlled 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.
- Conditions
- Gastric Cancer (GC), Iron Deficiency Anemia (IDA), Post-Operative Anemia, Radical Gastrectomy
- Being tested
- Ferric Carboxymaltose (FCM), Iron Sucrose.
- Keywords
- Ferric Carboxymaltose, Iron Sucrose, Intravenous Iron Supplementation, Gastrectomy, Postoperative Iron Deficiency, Gastric Cancer Surgery, Iron-deficiency Anemia
- Medical subject headings
- Stomach Neoplasms, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Iron Sucrose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Postoperative Week 3
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: Baseline to postoperative Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaojian Niu,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhaojian Niu,MD, The Affiliated Hospital of Qingdao University
- Investigators
- zhaojian Niu, MD, PhD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772453
- Sponsor's protocol ID
- QYFYEC2026-107
- Acronym
- IRIS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No