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)

NCT03979131 ↗

Phase 2 Active not recruiting 40 enrolled Vall d'Hebron Institute of Oncology
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

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody — —
Background Docetaxel Small molecule — —
Background Leucovorin Small molecule — —
Background Oxaliplatin Small molecule — —
Background fluorouracil Small molecule — —