A pragmatic phase II trial evaluating treatment strategies using immune checkpoint inhibitors for metastatic esophageal cancer patients with severe dysphagia
This is a randomized, non-comparative, pragmatic phase II trial enrolling untreated patients with metastatic esophageal or esophagogastric squamous cell carcinoma and severe dysphagia. Patients are randomized to receive either FP plus ICI (arm A) or FP plus ICI following RT/CRT (arm B) in accordance with clinical practice. The primary endpoint is dysphagia relief rate at 9 weeks from the initiation of treatment. This trial has been ongoing since December 2024.
Authors
- Y. Nagata
- T. Masuishi
- M. Taguri
- H. Arai
- N. Izawa
- C. Inagaki
- T. Tsushima
- K. Harada
- K. Hirata
- Y. Nagatani
- A. Sugaya
- Y. Sunakawa
- T. Moriwaki
Institutions
- Tokyo Medical University (JP)
- St. Marianna University School of Medicine (JP)
- Keio University (JP)
- Shizuoka Cancer Center (JP)
- Kurashiki Central Hospital (JP)
- Kobe University Hospital (JP)
- Aichi Cancer Center (JP)
- Ibaraki Prefectural Central Hospital (JP)
- Kindai University (JP)
Publication Details
- Journal
- ESMO Gastrointestinal Oncology
- Published
- 2026-02-24
- DOI
- https://doi.org/10.1016/j.esmogo.2026.100310
- Primary Topic
- Esophageal Cancer Research and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Kagoshima University
- Taiho Pharmaceutical
- Asahikawa Medical University
- Kindai University
- EA Pharma Co., Ltd.
- University of Toyama
- Kanazawa University
- Keio University
- Eisai
- Jichi Medical University
- Kanazawa Medical University
- Wakayama Medical University
- University of Tokyo
- Astellas Pharma
- Nara Medical University
- Kitasato University
- University of the Ryukyus
- Servier
- Yakult Honsha
- Chugai Pharmaceutical
- Eli Lilly Japan
- Daiichi Sankyo Europe