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.
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
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)
Parallel
Ferinject
Drug* 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 management
Other intervention* 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.
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
Change of Hb concentration
Change of Hb concentration from 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
Change in serum ferritin
Change in serum iron, ferritin(ng/dL) from 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
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