Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer

Summary

This study assumes that to achieve significant therapeutic efficacy in advanced pancreatic cancer with immunotherapy, the immune system must remain relatively intact. Therefore, early use, low tumor load, adequate organ function, and slow growth of the tumor are the key points. Stage IV pancreatic adenocarcinoma patients with limited metastatic lesions and adequate organ function will be enrolled. Gemcitabine plus S-1 (GS) will be administered initially, and then CA 19-9 will be evaluated. Those fulfilling pre-defined criteria of CA 19-9 will receive nivolumab add-on therapy.

Timeline

Start

2020-07-01

Primary completion

2022-07-01

Completion

2022-12-31

Publications

• Results Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
• Results Weiss GJ, Blaydorn L, Beck J, Bornemann-Kolatzki K, Urnovitz H, Schutz E, Khemka V. Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Invest New Drugs. 2018 Feb;36(1):96-102. doi: 10.1007/s10637-017-0525-1. Epub 2017 Nov 8.
• Yang SH, Chen BB, Lee JC, Kuo YT, Kuo SH, Cheng AL, Yeh KH. Incorporating nivolumab with preceded gemcitabine and S-1 chemotherapy for patients of metastatic pancreatic cancer: a pilot study. Am J Cancer Res. 2025 Sep 25;15(9):4108-4120. doi: 10.62347/NJOX8790. eCollection 2025.

Drugs

Indications