mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)

Summary

This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55 patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of the esophagus. Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5- fluorouracil. Following surgery, pathologic response will be assessed. Patients will then receive adjuvant therapy consisting of 4 cycles of mDCF + avelumab. Patients will be followed to assess two-year disease-free survival rates. The primary objective of this study is to assess the effect on pathologic complete response rate (pCR) of adding avelumab to an mDCF regimen. The secondary objectives of this study are to determine the safety of adding avelumab to an mDCF regimen and assess its effect on two-year disease-free survival.

Timeline

Start

2018-02-22

Primary completion

2020-12

Completion

2023-12

Publications

• Alcindor T, Tankel J, Fiset PO, Pal S, Opu T, Strasser M, Dehghani M, Bertos N, Zuo D, Mueller C, Cools-Lartigue J, Hickeson M, Marcus V, Camilleri-Broet S, Spatz A, Evaristo G, Farag M, Artho G, Elkrief A, Saleh R, Bailey S, Park M, Huang S, Sangwan V, Ferri L. Phase 2 trial of perioperative chemo-immunotherapy for gastro-esophageal adenocarcinoma: The role of M2 macrophage landscape in predicting response. Cell Rep Med. 2025 Apr 15;6(4):102045. doi: 10.1016/j.xcrm.2025.102045.

Drugs

Indications