A Phase 4 interventional study of Ferric Carboxymaltose (FCM) and Iron Sucrose. in Gastric Cancer (GC), Iron Deficiency Anemia (IDA) and Post-Operative Anemia, sponsored by Zhaojian Niu,MD. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Zhaojian Niu,MD · Phase 4, Interventional, and Treatment
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 160 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →This is the only study on the registry with Zhaojian Niu,MD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 synthesis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Single-dose intravenous infusion administered on postoperative day 1.
Repeated intravenous infusions to reach equivalent total iron dose.
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
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
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
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Nov 2027, 15 months later.
Of 27 phase 4 interventional studies under Stomach Neoplasms, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 17. This study's planned 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric carboxymaltose