Actively Recruiting
Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
Led by Asan Medical Center · Updated on 2026-04-03
330
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the safety and effectiveness of intravenous ferric carboxymaltose (IV FCM) in patients with advanced gastric cancer (AGC) who are receiving palliative chemotherapy. Gastric cancer patients often face iron-deficiency anemia (IDA) due to chronic blood loss, poor nutrition, and interventions that affect iron absorption. The study focuses on patients receiving fluoropyrimidine and platinum-based chemotherapy to understand how IV FCM impacts anemia and treatment outcomes in this first-line palliative setting. Participants are randomized into two groups. One group receives IV FCM infusions starting with a high dose of 1,000 mg iron on the first chemotherapy day, with possible additional doses at weeks 6, 12, 24, 36, and 48 if criteria are met. The other group receives conservative management, including oral iron supplements like ferrous sulfate, with IV FCM allowed after 48 weeks if needed. Treatments are given under clinical supervision, with IV FCM diluted and infused over 15 or 6 minutes depending on the dose. During the study, participants undergo regular blood tests at multiple timepoints up to 48 weeks to monitor hemoglobin levels, iron status, and related markers. Tumor response is assessed every 6 to 8 weeks for up to 24 months. Progression-free survival and overall survival are also tracked throughout the study period. The primary goal is to measure changes in hemoglobin concentration from baseline to 12 weeks. Safety and efficacy data are collected to inform future treatment strategies for anemia in advanced gastric cancer.
CONDITIONS
Brief Title
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at study registration
- Eastern Cooperative Oncology Group performance status of 2 or less
- Histological or cytological confirmation of gastric or gastroesophageal junction adenocarcinoma
- Locally advanced unresectable or metastatic disease
- No prior palliative systemic antitumor treatment for advanced or recurrent gastric or GEJ adenocarcinoma
- Planned first-line palliative chemotherapy with fluoropyrimidine and platinum-based regimen, including targeted or immunotherapy
- Life expectancy of at least 24 weeks
- Iron-deficiency anemia with hemoglobin between 8 and less than 11 g/dL
- Absolute iron deficiency (serum ferritin less than 100 ng/mL) or functional iron deficiency (transferrin saturation less than 50% and serum ferritin between 100 and 500 ng/mL)
You will not qualify if you...
- Body weight less than 35 kg
- Immediate need for transfusion or hemoglobin less than 8 g/dL
- No iron deficiency or possible functional iron deficiency with serum ferritin over 500 ng/mL or transferrin saturation 50% or higher
- Anemia caused by factors other than cancer or chemotherapy, such as vitamin B12 or folate deficiency, hemolysis, or myelodysplastic syndromes
- Ongoing or active bleeding like hematemesis, melena, or hematochezia
- Neoplastic bone marrow infiltration
- Treatment with erythropoiesis-stimulating agents, intravenous or oral iron, or red blood cell transfusion within 4 weeks before randomization
- Iron overload or disorders affecting iron use, including history of hemochromatosis or hemosiderosis
- Known hypersensitivity to study products or serious allergic reactions to parenteral iron
- Severe allergies including drug allergies, severe asthma, eczema, or other atopic conditions, and immune or inflammatory diseases like lupus or rheumatoid arthritis
- Reduced kidney function, including dialysis or serum creatinine 2.0 mg/dL or higher, or low estimated glomerular filtration rate
- Chronic liver disease or elevated liver enzymes over three times normal
- Active acute or chronic infections
- Other significant medical conditions that increase risk or interfere with study assessments, such as uncontrolled hypertension, cardiac disease, thromboembolic disease, uncontrolled diabetes, neurological or psychiatric disorders
- Pregnancy, breastfeeding, or inadequate contraception in women of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive intravenous ferric carboxymaltose (IV FCM) infusions to treat iron-deficiency anemia during their palliative chemotherapy. The initial IV FCM dose is given on the first day of chemotherapy, with additional doses at 6, 12, 24, 36, and 48 weeks for those with continued anemia. Participants in the control group receive oral iron or conservative management according to physician's choice.
1 infusion visit at start and additional visits at 6, 12, 24, 36, and 48 weeks as needed
Duration - Up to 48 weeks
Participants are monitored for treatment outcomes including changes in hemoglobin levels and safety for up to 48 weeks after starting treatment.
Visits at 3, 6, 9, 12, 24, 36, and 48 weeks for assessments
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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