NCT05226169 Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
| NCT ID | NCT05226169 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Asan Medical Center |
| Condition | Advanced Gastric Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2022-04-29 |
| Primary Completion | 2026-11-30 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 19 years at the time of study registration 2. Eastern Cooperative Oncology Group performance status ≤ 2 3. Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma 4. Locally advanced unresectable or metastatic disease 5. Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma 6. Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy 7. Life expectancy ≥24 weeks 8. IDA 1. Hb 8 to \<11 g/dL 2. Absolute ID (serum ferritin \< 100 ng/mL) OR functional ID (TSAT\* \< 50% and serum ferritin 100-500 ng/mL) * TSAT = (serum iron level x 100)/ total iron-binding capacity (TIBC) Exclusion Criteria: 1. Body weight \< 35 kg 2. Immediate need for transfusion or Hb \< 8 g/dL 3. Possible functional ID or No ID (serum ferritin \> 500 ng/mL OR TSAT ≥ 50%) 4. Anemia