A multicenter Phase II study of mFOLFOX6 plus nivolumab for gastric cancer with severe peritoneal metastases: WJOG16322G
Advanced gastric cancer (AGC) patients with severe peritoneal metastases (SPM), characterized by massive ascites and/or inadequate oral intake, have a poor prognosis with the median overall survival of around 7 months, even when treated with fluorouracil/l-leucovorin plus oxaliplatin (mFOLFOX6), despite being a treatment options for these patients demonstrated in the WJOG10517G study. However, these patients were excluded from pivotal Phase III trials, including the CheckMate 649 study, which demonstrated the benefit of adding nivolumab to mFOLFOX6, due to tumor-related complications. Given the lack of data on the efficacy and safety of combining nivolumab with mFOLFOX6 for AGC patients with SPM, we initiated a Phase II study to evaluate this combination. The primary endpoint was the 1-year survival rate.<b>Clinical trial registration:</b> Japan Registry of Clinical Trials (jRCTs) 041220164.
Authors
- Yosuke Kito
- Hisato Kawakami (ORCID: https://orcid.org/0000-0002-3280-4850)
- Yoshiyuki Yamamoto (ORCID: https://orcid.org/0000-0002-1271-3521)
- Kei Muro
- Toshiki Masuishi (ORCID: https://orcid.org/0000-0002-7521-1596)
- Toshihiko Matsumoto (ORCID: https://orcid.org/0000-0002-7397-1006)
- Kenichi Yoshimura (ORCID: https://orcid.org/0000-0001-7393-6932)
- Hidekazu Hirano (ORCID: https://orcid.org/0000-0003-1343-1419)
- Fumiyasu Hanamura
- Keiko Minashi (ORCID: https://orcid.org/0000-0003-1513-7117)
- Naoki Takahashi (ORCID: https://orcid.org/0000-0001-6377-9507)
- Takayuki Ando (ORCID: https://orcid.org/0000-0001-8219-976X)
- Chiho Kudo (ORCID: https://orcid.org/0000-0002-1689-3566)
- Mitsuhiro Furuta (ORCID: https://orcid.org/0000-0003-4706-2615)
- Takatsugu Ogata (ORCID: https://orcid.org/0000-0003-1059-5215)
- Naoki Izawa
- Munehiro Wakabayashi (ORCID: https://orcid.org/0009-0001-8844-6845)
- Kentaro Kawakami
Institutions
- Toho University (JP)
- St. Marianna University School of Medicine (JP)
- Kanagawa Prefectural Hospital Organization (JP)
- National Cancer Center (US)
- Hamanomachi Hospital (JP)
- University of Tsukuba Hospital (JP)
- Chiba Cancer Center (JP)
- Ichinomiya Kenshin College (JP)
- Ishikawa Prefectural Central Hospital (JP)
- Saitama Cancer Center (JP)
- Keiyukai Sapporo Hospital (JP)
- Hiroshima University Hospital (JP)
- Aichi Cancer Center (JP)
- National Cancer Center Hospital East (JP)
- Osaka International Cancer Institute (JP)
- University of Toyama (JP)
- Kanagawa Cancer Center
- Kindai University (JP)
Publication Details
- Journal
- Future Oncology
- Published
- 2025-06-06
- DOI
- https://doi.org/10.1080/14796694.2025.2514935
- Citations
- 2
- Primary Topic
- Gastric Cancer Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 3.04
Funders
- Ono Pharmaceutical