Evaluating Ferric Carboxymaltose for Patients with Advanced Gastric Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating NKT3964 for Adults with Advanced Solid Tumors

  This study is testing a new drug called NKT3964 to see if it can safely help adults with advanced solid tumors, like ovarian or triple-negative breast cancer, after other treatments have failed.

  Recruiting at 17 sites Phase 1 NiKang Therapeutics, Inc. · Little Rock, Arkansas and 20 other locations · NCT06586957

• Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer

  This study is testing two different chemotherapy plans for people with advanced stomach cancer to see which one helps them better tolerate treatment and successfully have surgery.

  Recruiting at 2 sites Phase 2/3 Ukrainian Society of Clinical Oncology · Vilnius and 1 other locations · NCT06028737

• At-home cancer treatment versus clinic-based treatment for advanced cancer patients

  This study tests whether giving cancer treatment at home is better for comfort and satisfaction compared to getting it at a clinic for people with advanced cancer.

  Recruiting at 2 sites Phase 2 Mayo Clinic · Jacksonville, Florida and 1 other locations · NCT05969860

• Treatment for advanced pancreatic and gastric cancers using Claudin18.2 CAR-T cells

  This study tests a new CAR-T cell treatment for people with advanced pancreatic and gastric cancers to see if it can help them after other treatments have not worked.

  Recruiting Shenzhen University General Hospital · Shenzhen, Guangdong · NCT05620732

• Using immunotherapy and chemotherapy for advanced gastric cancer treatment

  This study is testing if combining immunotherapy with chemotherapy can help people with advanced gastric cancer feel better and improve their treatment outcomes.

  Recruiting Qilu Hospital of Shandong University · Jinan, Shandong · NCT06727981

• Combining two anticancer drugs for treating advanced gastric and gastroesophageal junction cancers

  This study is testing a new combination of two cancer drugs to see if they can help people with advanced HER2-positive gastric or gastroesophageal junction cancers feel better and live longer.

  Recruiting Phase 1 National Cancer Institute (NCI) · Houston, Texas · NCT06364410

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.