drugset

drugset / Trial / NCT03914443

A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma

NCT03914443 ↗

Phase 1 Completed 37 enrolled National Cancer Center, Japan Fiverings Co., Ltd. · collab Ono Pharmaceutical Co., Ltd. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.

Timeline

Start: 2019-05-07
Primary completion: 2025-03-31
Completion: 2025-03-31

Publications

Yamamoto S, Kato K, Daiko H, Kojima T, Hara H, Abe T, Tsubosa Y, Nagashima K, Aoki K, Mizoguchi Y, Kitano S, Yachida S, Shiba S, Kitagawa Y. Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E). Future Oncol. 2020 Jul;16(19):1351-1357. doi: 10.2217/fon-2020-0189. Epub 2020 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	70 mg/m2	—
Subject	Cisplatin	Other / unclassified	80 mg/m2	—
Subject	DTX	Unknown	70 mg/m2	—
Subject	Nivolumab	Monoclonal antibody	360 mg	—
Subject	fluorouracil	Small molecule	750 mg/m2	—
Subject	fluorouracil	Small molecule	800 mg/m2	—

Indications