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).

Publisher: Oxford University Press Country of Publication: England NLM ID: 0313225 Publication Model: Print Cited Medium: Internet ISSN: 1465-3621 (Electronic) Linking ISSN: 03682811 NLM ISO Abbreviation: Jpn J Clin Oncol Subsets: MEDLINE

Publication: Oxford : Oxford University Press
Original Publication: Tokyo, Foundation of Clinical Oncology.

Pancreatic Neoplasms*/therapy ; Pancreatic Neoplasms*/pathology ; Pancreatic Neoplasms*/drug therapy ; Nivolumab*/therapeutic use ; Nivolumab*/administration & dosage ; Oxonic Acid*/administration & dosage ; Oxonic Acid*/therapeutic use ; Tegafur*/administration & dosage ; Tegafur*/therapeutic use ; Chemoradiotherapy*/methods ; Drug Combinations* ; Antineoplastic Combined Chemotherapy Protocols*/therapeutic use; Humans ; Male ; Female ; Adult ; Middle Aged ; Aged ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic ; Immune Checkpoint Inhibitors/therapeutic use

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).
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Keywords: borderline resectable; chemoradiotherapy; nivolumab; pancreatic cancer; unresectable locally advanced

150863-82-4 (S 1 (combination))
31YO63LBSN (Nivolumab)
5VT6420TIG (Oxonic Acid)
1548R74NSZ (Tegafur)
0 (Drug Combinations)
0 (Immune Checkpoint Inhibitors)

Date Created: 20240628 Date Completed: 20241104 Latest Revision: 20241104

20241104

10.1093/jjco/hyae084

38941345