Advanced Gastric CarcinomaPhase 3NCT05226169
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
A Phase 3 study testing Ferinject and Conservative management in people with Advanced Gastric Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Gastric Carcinoma
- What is being tested?
- Ferinject and Conservative management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2022to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years at the time of study registration
- Eastern Cooperative Oncology Group performance status ≤ 2
- Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Locally advanced unresectable or metastatic disease
- Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma
- Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy
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- Life expectancy ≥24 weeks
- IDA
- Hb 8 to <11 g/dL
- Absolute ID (serum ferritin < 100 ng/mL) OR functional ID (TSAT* < 50% and serum ferritin 100-500 ng/mL)
- TSAT = (serum iron level x 100)/ total iron-binding capacity (TIBC)
Who cannot join
- Body weight < 35 kg
- Immediate need for transfusion or Hb < 8 g/dL
- Possible functional ID or No ID (serum ferritin > 500 ng/mL OR TSAT ≥ 50%)
- Anemia attributable to factors other than cancer or chemotherapy (e.g., vitamin B12 and/or serum folate deficiency; hemolysis; or myelodysplastic syndromes)
- Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia)
- Neoplastic bone marrow infiltration
Show all 15Show fewer
- History of ESA, IV or oral iron therapy, and/or RBC transfusion 4 weeks prior to randomization
- Iron overload or disturbances in utilization of iron (e.g., personal or family history of hemochromatosis and hemosiderosis)
- Known hypersensitivity to any of the required study products or known serious hypersensitivity to other parenteral iron products
- Known severe allergies including drug allergies, history of severe asthma, eczema or other atopic allergies, and in subjects with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis)
- Decreased renal function including renal dialysis (previous, current or planned within the next 6 months,) or serum creatinine levels ≥ 2.0 mg/dL, or estimated glomerular filtration rate < 30 mL/min/1.73 m2
- Chronic liver disease (including active hepatitis) and/or aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 times the upper limit of the normal range
- Active acute or chronic infections (assessed by clinical judgment)
- Other significant medical condition(s) in the opinion of the investigator with an anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject or may interfere with study assessments, outcomes (e.g., uncontrolled hypertension, active cardiac disease, thromboembolic disease, or uncontrolled diabetes mellitus, neurological or psychiatric disorders)
- Pregnancy (e.g., positive human chorionic gonadotropin test) or breast-feeding. If the subject is of childbearing potential and does, not use adequate contraceptive precautions. The subject must agree to use adequate contraception during the study and for 1 month after the last dose of study treatment. A highly effective method of birth control must be used.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Min-Hee Ryu, MD., Ph.D., +82-10-5285-9492, miniryu@amc.seoul.kr
Min-Hee Ryu, M.D., Ph.D.
About this study
Official title: Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
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.
Read the detailed description
Gastric cancer is associated with chronic blood loss, poor nutrition, and surgical interventions interfering with iron absorption, all of which synergistically increase the risk of iron-deficiency anemia (IDA). A retrospective review of gastric cancer reported that at the time of gastric cancer diagnosis, the prevalence of anemia was 58.7% and the overall prevalence of IDA was 40%. Moreover, patients with unresectable locally advanced or metastatic gastric cancer are treated with myelosuppressive chemotherapies, which further increases the risk for anemia.
The absorption of oral iron in gastric cancer patients is limited due to malabsorption, ongoing gastrointestinal bleeding, and lack of adherence to treatment due to dyspepsia, vomiting, abdominal pain, diarrhea, and constipation. Therefore, IV iron may be preferable due to easy administration, effective iron absorption, and infrequent complications in gastric cancer patients.
- There are a number of IV iron formulations in the market; the recommended IV iron preparations are low-molecular-weight iron dextran, ferric gluconate, iron sucrose, ferric carboxymaltose (FCM), and ferumoxytol. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) is a stable colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose, which allows slow and prolonged iron release, and is given as a single high-dose (1,000 mg of iron) in a 15-minute infusion. Based on extensive experience in clinical trial and real-world settings, IV FCM is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anemia in patients with ID or IDA of various etiologies.
FCM was effective in patients with active malignancy and IDA (n=420), and hematological malignancies or solid tumors and anemia (n=367) in two real-world, noninterventional studies conducted in Germany and France. Recently, two prospective studies conducted in South Korea have reported a significant increase in Hb levels by treatment with IV FCM in patients with solid cancers (including gastric cancer) receiving chemotherapy and in patients with acute isovolemic anemia following gastrectomy.
Therefore, the main objective of this study is to evaluate the efficacy and safety of IV FCM 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
- Advanced Gastric Carcinoma
- Being tested
- Ferinject, Conservative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called IV FCM
- Patients will receive an IV FCM (1,000 mg iron) infusion on the first day (visit 1) of chemotherapy. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) will be diluted in 250 ml of sterile 0.9% normal saline by an aseptic technique and infused over 15 min under the supervision of a clinician.
- Patients with a Hb level ≤ 10 g/dL and ID (serum ferritin < 100 ng/mL or TSAT < 50% and serum ferritin 100-500 ng/mL) will receive an additional dose of 500 mg of IV FCM at 6, 12, 24, 36, and 48 weeks. FCM will be diluted in 100 ml of sterile 0.9% normal saline by an aseptic technique and infused over 6 min under the supervision of a clinician.
Conservative managementOther
- Patients with absolute (must be administered) or functional (according to the physician's choice) IDA in the control arm will be received oral iron, administered as Feroba-You 256mg once or twice a day. Advice will be given regarding ingestion without food and with liquid high in ascorbic acid to maximize enteric absorption.
- If patients in the control arm still meet the absolute or functional IDA at the end of study (at 48 weeks), they can receive IV FCM (1,000 mg) according to the physician's decision.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment arm : IV FCM | Experimental | Intravenous ferric carboxymaltose Receives: Drug: Ferinject |
| Control treatment arm: Conservative management | Active comparator | Conservative management
* Absolute IDA: oral ferrous sulfate
* Functional IDA: no treatment or oral ferrous sulfate according to the physician's choice
* Other IV iron or PRC transfusion or ESA therapy is not allowed Receives: Other: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change of Hb concentration
Maximum change of Hb concentration from baseline to 12 weeks (or first RBC transfusion and/or ESA, or study withdrawl, or death, whichever will be first) without RBC transfusion and/or ESA
Measured: baseline to 12 weeks
Secondary outcomes (8)
Change of Hb concentration
Change of Hb concentration from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Measured: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum iron
Change in serum iron from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Measured: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum ferritin
Change in serum iron, ferritin(ng/dL) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Measured: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum TIBC
Change in serum TIBC(µg/dL) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Measured: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum TSAT
Change in serum TSAT(%) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Measured: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Tumor response
according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: every 6-8weeks, assessed up to 24 months
PFS
time from the date of first administration of palliative first-line chemotherapy to the date of the first objectively documented tumor progression or death, whichever occurs first)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
time from the date of first administration of palliative first-line chemotherapy to the date of death due to any cause
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start29 Apr 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Hee Ryu, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226169
- Sponsor's protocol ID
- AMC2102
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
- ClinicalTrials.gov ID
- NCT05226169
- Acronym / sponsor ID
- AMC2102
- Conditions
- Advanced Gastric Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastric cancer is associated with chronic blood loss, poor nutrition, and surgical interventions interfering with iron absorption, all of which synergistically increase the risk of iron-deficiency anemia (IDA). A retrospective review of gastric cancer reported that at the time of gastric cancer diagnosis, the prevalence of anemia was 58.7% and the overall prevalence of IDA was 40%. Moreover, patients with unresectable locally advanced or metastatic gastric cancer are treated with myelosuppressive chemotherapies, which further increases the risk for anemia.
The absorption of oral iron in gastric cancer patients is limited due to malabsorption, ongoing gastrointestinal bleeding, and lack of adherence to treatment due to dyspepsia, vomiting, abdominal pain, diarrhea, and constipation. Therefore, IV iron may be preferable due to easy administration, effective iron absorption, and infrequent complications in gastric cancer patients.
- There are a number of IV iron formulations in the market; the recommended IV iron preparations are low-molecular-weight iron dextran, ferric gluconate, iron sucrose, ferric carboxymaltose (FCM), and ferumoxytol. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) is a stable colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose, which allows slow and prolonged iron release, and is given as a single high-dose (1,000 mg of iron) in a 15-minute infusion. Based on extensive experience in clinical trial and real-world settings, IV FCM is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anemia in patients with ID or IDA of various etiologies.
FCM was effective in patients with active malignancy and IDA (n=420), and hematological malignancies or solid tumors and anemia (n=367) in two real-world, noninterventional studies conducted in Germany and France. Recently, two prospective studies conducted in South Korea have reported a significant increase in Hb levels by treatment with IV FCM in patients with solid cancers (including gastric cancer) receiving chemotherapy and in patients with acute isovolemic anemia following gastrectomy.
Therefore, the main objective of this study is to evaluate the efficacy and safety of IV FCM 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm : IV FCM | Experimental | Drug: FerinjectIntravenous ferric carboxymaltose |
| Control treatment arm: Conservative management | Active comparator | Other: Conservative managementConservative management * Absolute IDA: oral ferrous sulfate * Functional IDA: no treatment or oral ferrous sulfate according to the physician's choice * Other IV iron or PRC transfusion or ESA therapy is not allowed |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 19 years at the time of study registration
- Eastern Cooperative Oncology Group performance status ≤ 2
- Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Locally advanced unresectable or metastatic disease
- Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma
Key exclusion criteria (15 listed)
- Body weight < 35 kg
- Immediate need for transfusion or Hb < 8 g/dL
- Possible functional ID or No ID (serum ferritin > 500 ng/mL OR TSAT ≥ 50%)
- Anemia attributable to factors other than cancer or chemotherapy (e.g., vitamin B12 and/or serum folate deficiency; hemolysis; or myelodysplastic syndromes)
- Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectAlso: IV FCM* Patients will receive an IV FCM (1,000 mg iron) infusion on the first day (visit 1) of chemotherapy. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) will be diluted in 250 ml of sterile 0.9% normal saline by an aseptic technique and infused over 15 min under the supervision of a clinician. * Patients with a Hb level ≤ 10 g/dL and ID (serum ferritin < 100 ng/mL or TSAT < 50% and serum ferritin 100-500 ng/mL) will receive an additional dose of 500 mg of IV FCM at 6, 12, 24, 36, and 48 weeks. FCM will be diluted in 100 ml of sterile 0.9% normal saline by an aseptic technique and infused over 6 min under the supervision of a clinician. | Drug | Active treatment arm : IV FCM |
| Conservative management* Patients with absolute (must be administered) or functional (according to the physician's choice) IDA in the control arm will be received oral iron, administered as Feroba-You 256mg once or twice a day. Advice will be given regarding ingestion without food and with liquid high in ascorbic acid to maximize enteric absorption. * If patients in the control arm still meet the absolute or functional IDA at the end of study (at 48 weeks), they can receive IV FCM (1,000 mg) according to the physician's decision. | Other | Control treatment arm: Conservative management |
Primary outcome
Maximum change of Hb concentration
Time frame: baseline to 12 weeks
Maximum change of Hb concentration from baseline to 12 weeks (or first RBC transfusion and/or ESA, or study withdrawl, or death, whichever will be first) without RBC transfusion and/or ESA
8 secondary outcomes
Change of Hb concentration
Time frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum iron
Time frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum ferritin
Time frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum TIBC
Time frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Change in serum TSAT
Time frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
Tumor response
Time frame: every 6-8weeks, assessed up to 24 months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferinject and Conservative management in people with Advanced Gastric Carcinoma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min-Hee Ryu, PhD (82-2-3010-5935, miniryu@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum change of Hb concentration (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.