Study of Intravenous Ferric Carboxymaltose to Treat Iron-Deficiency Anemia in Adults with Advanced Gastric Cancer Undergoing Palliative Chemotherapy

What this Trial Is About

This research evaluates the safety and effectiveness of intravenous ferric carboxymaltose IV FCM in patients with advanced gastric cancer AGC who are receiving palliative chemotherapy. Gastric cancer patients often face iron-deficiency anemia IDA due to chronic blood loss, poor nutrition, and interventions that affect iron absorption. The study focuses on patients receiving fluoropyrimidine and platinum-based chemotherapy to understand how IV FCM impacts anemia and treatment outcomes in this first-line palliative setting. Participants are randomized into two groups. One group receives IV FCM infusions starting with a high dose of 1,000 mg iron on the first chemotherapy day, with possible additional doses at weeks 6, 12, 24, 36, and 48 if criteria are met. The other group receives conservative management, including oral iron supplements like ferrous sulfate, with IV FCM allowed after 48 weeks if needed. Treatments are given under clinical supervision, with IV FCM diluted and infused over 15 or 6 minutes depending on the dose. During the study, participants undergo regular blood tests at multiple timepoints up to 48 weeks to monitor hemoglobin levels, iron status, and related markers. Tumor response is assessed every 6 to 8 weeks for up to 24 months. Progression-free survival and overall survival are also tracked throughout the study period. The primary goal is to measure changes in hemoglobin concentration from baseline to 12 weeks. Safety and efficacy data are collected to inform future treatment strategies for anemia in advanced gastric cancer.

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