Evaluating Ferric Carboxymaltose for Patients with Advanced Gastric Cancer
Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
This study is testing if a single high-dose infusion of ferric carboxymaltose can help improve treatment outcomes and manage anemia in patients with advanced gastric cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05226169 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) in patients with advanced gastric cancer who are undergoing palliative chemotherapy. It focuses on patients receiving a first-line treatment regimen that includes fluoropyrimidine and platinum-based therapies. The study will investigate how FCM can improve treatment outcomes and address iron-deficiency anemia, which is common in this patient population due to various factors such as chronic blood loss and malabsorption. By administering FCM as a single high-dose infusion, the study seeks to provide a more effective solution for managing anemia in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive palliative chemotherapy.
Not a fit: Patients who are severely anemic with a hemoglobin level below 8 g/dL or those requiring immediate transfusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and treatment outcomes for patients with advanced gastric cancer by effectively managing iron-deficiency anemia.
How similar studies have performed: Other studies have shown promising results with intravenous iron formulations in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 19 years at the time of study registration
2. Eastern Cooperative Oncology Group performance status ≤ 2
3. Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
4. Locally advanced unresectable or metastatic disease
5. Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma
6. Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy
7. Life expectancy ≥24 weeks
8. IDA
1. Hb 8 to \<11 g/dL
2. 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)
Exclusion Criteria:
1. Body weight \< 35 kg
2. Immediate need for transfusion or Hb \< 8 g/dL
3. Possible functional ID or No ID (serum ferritin \> 500 ng/mL OR TSAT ≥ 50%)
4. Anemia attributable to factors other than cancer or chemotherapy (e.g., vitamin B12 and/or serum folate deficiency; hemolysis; or myelodysplastic syndromes)
5. Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia)
6. Neoplastic bone marrow infiltration
7. History of ESA, IV or oral iron therapy, and/or RBC transfusion 4 weeks prior to randomization
8. Iron overload or disturbances in utilization of iron (e.g., personal or family history of hemochromatosis and hemosiderosis)
9. Known hypersensitivity to any of the required study products or known serious hypersensitivity to other parenteral iron products
10. 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)
11. 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
12. Chronic liver disease (including active hepatitis) and/or aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 times the upper limit of the normal range
13. Active acute or chronic infections (assessed by clinical judgment)
14. 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)
15. 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.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Min-Hee Ryu, PhD
- Email: miniryu@amc.seoul.kr
- Phone: 82-2-3010-5935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.