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Yusuke Sano, Masashi Kanai, Chigusa Morizane, Keita Sasaki, Michio Yoshimura, Yoshinori Ito, Junji Furuse, Masato Ozaka, Haruhiko Fukuda, Makoto Ueno, on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group, Protocol digest of a randomized phase III trial comparing S-1-based chemoradiotherapy with/without nivolumab for unresectable locally advanced or borderline resectable pancreatic cancer: JCOG1908E (PENETRATE), Japanese Journal of Clinical Oncology, Volume 54, Issue 11, November 2024, Pages 1214–1218, https://doi.org/10.1093/jjco/hyae084
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Abstract
Pancreatic cancer remains a highly lethal disease with a 5-year survival proportion of <10%. Chemoradiotherapy is a treatment option for unresectable locally advanced (UR-LA) or borderline resectable (BR) pancreatic cancer, but its efficacy is not sufficient. Induction of the synergistic effect of irradiation and immune checkpoint inhibitors can be an attractive strategy. An open-label randomized phase III trial has been conducted since October 2020 to confirm the superiority of nivolumab plus S-1-based chemoradiotherapy over S-1-based chemoradiotherapy alone in patients with UR-LA or BR pancreatic cancer. A total of 216 patients will be enrolled in 14 institutions within 3.5 years. The primary endpoint of the safety run-in part is dose-limiting toxicity, and that of the phase III part is overall survival. This trial was registered at the Japan Registry of Clinical Trials as jRCT2080225361 (https://jrct.niph.go.jp/latest-detail/jRCT2080225361).