Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Ferinject
  • Conservative management

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators