Actively Recruiting
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
Led by Asan Medical Center · Updated on 2026-04-03
330
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of this study is to evaluate the efficacy and safety of IV FCM(ferric carboxymaltose) in patients with AGC receiving palliative chemotherapy. This study will also evaluate the effect of IV FCM on the treatment outcomes of palliative chemotherapy in patients with gastric cancer receiving fluoropyrimidine and platinum-based regimen in the same 1st-line palliative setting.
CONDITIONS
Official 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 0 to 2
- Histologically or cytologically confirmed 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
- Scheduled for first-line palliative fluoropyrimidine and platinum-based chemotherapy, including targeted or immunotherapy
- Life expectancy of 24 weeks or more
- Iron-deficiency anemia defined as hemoglobin 8 to less than 11 g/dL with absolute iron deficiency (serum ferritin less than 100 ng/mL) or functional iron deficiency (transferrin saturation less than 50% and serum ferritin 100 to 500 ng/mL)
You will not qualify if you...
- Body weight less than 35 kg
- Immediate need for blood transfusion or hemoglobin less than 8 g/dL
- Possible functional iron deficiency or no iron deficiency (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 visible bleeding (such as vomiting blood, black stools, or blood in stool)
- Bone marrow infiltration by cancer
- History of erythropoiesis-stimulating agents, intravenous or oral iron therapy, or red blood cell transfusion within 4 weeks before randomization
- Iron overload or disorders affecting iron use (including personal or family history of hemochromatosis or hemosiderosis)
- Known hypersensitivity to study products or severe allergies including drug allergies, severe asthma, eczema, or other atopic allergies, or immune or inflammatory diseases
- Reduced kidney function, including dialysis, serum creatinine 2.0 mg/dL or higher, or estimated glomerular filtration rate less than 30 mL/min/1.73 m2
- Chronic liver disease or liver enzyme levels three times above normal
- Active acute or chronic infections
- Other significant medical conditions or disorders that increase risk or interfere with study assessments
- Pregnancy or breastfeeding without adequate contraception during the study and for one month after the last treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, PhD
CONTACT
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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