drugset / Trial / NCT03979131
Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC)
NaSingle-groupOpen-labelTreatment
Summary
Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer (GC) or Gastroesphageal Junction cancer (GEJC) The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response. Conclusively, the survival of these patients would improve. The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) improves efficacy in terms of pathological complete response (pCR) rate, in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting.
Timeline
- Start
- 2019-08-22
- Primary completion
- 2023-03-15
- Completion
- 2026-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |