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

PHASE3RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

April 29, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2024

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."

Trial Locations (1)

138-736

RECRUITING

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT05226169 - Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC) | Biotech Hunter | Biotech Hunter