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

NCT05226169 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Gastric Carcinoma

Interventions

DRUG

Ferinject

* 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.

OTHER

Conservative management

* 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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226169 on ClinicalTrials.gov