FLOT Combined With PD-1 in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis

Summary

In this study, patients with advanced gastric adenocarcinoma whose peritoneal metastasis and peritoneal nodule pathologically confirmed metastasis and/or exfoliative cytology were confirmed as the clinical stage of peritoneal metastasis, who had not received treatment before, were invited to participate in the study.To evaluate the surgical conversion rate and tumor regression grade (TRG grade) of patients with stage gastric cancer with peritoneal metastasis using docetaxel, oxaliplatin, fluorouracil (FLOT regimen) combined with teriprizumab (PD-1).

Timeline

Start

2021-04-16

Primary completion

2022-05

Completion

2023-05

Publications

• Background Yamamoto M, Sakaguchi Y, Matsuyama A, Yoshinaga K, Tsutsui S, Ishida T. Surgery after preoperative chemotherapy for patients with unresectable advanced gastric cancer. Oncology. 2013;85(4):241-7. doi: 10.1159/000354420. Epub 2013 Oct 4.
• Background Yonemura Y, Bandou E, Kawamura T, Endou Y, Sasaki T. Quantitative prognostic indicators of peritoneal dissemination of gastric cancer. Eur J Surg Oncol. 2006 Aug;32(6):602-6. doi: 10.1016/j.ejso.2006.03.003. Epub 2006 Apr 17.
• Background Kitayama J, Ishigami H, Yamaguchi H, Yamashita H, Emoto S, Kaisaki S, Watanabe T. Salvage gastrectomy after intravenous and intraperitoneal paclitaxel (PTX) administration with oral S-1 for peritoneal dissemination of advanced gastric cancer with malignant ascites. Ann Surg Oncol. 2014 Feb;21(2):539-46. doi: 10.1245/s10434-013-3208-y. Epub 2013 Aug 22.
• Background Bismuth H, Adam R. Reduction of nonresectable liver metastasis from colorectal cancer after oxaliplatin chemotherapy. Semin Oncol. 1998 Apr;25(2 Suppl 5):40-6.
• Background Nakajima T, Ota K, Ishihara S, Oyama S, Nishi M, Ohashi Y, Yanagisawa A. Combined intensive chemotherapy and radical surgery for incurable gastric cancer. Ann Surg Oncol. 1997 Apr-May;4(3):203-8. doi: 10.1007/BF02306611.
• Background Yamaguchi K, Yoshida K, Tanahashi T, Takahashi T, Matsuhashi N, Tanaka Y, Tanabe K, Ohdan H. The long-term survival of stage IV gastric cancer patients with conversion therapy. Gastric Cancer. 2018 Mar;21(2):315-323. doi: 10.1007/s10120-017-0738-1. Epub 2017 Jun 14.
• Background Yoshida K, Yamaguchi K, Okumura N, Tanahashi T, Kodera Y. Is conversion therapy possible in stage IV gastric cancer: the proposal of new biological categories of classification. Gastric Cancer. 2016 Apr;19(2):329-338. doi: 10.1007/s10120-015-0575-z. Epub 2015 Dec 7.
• Background Zurleni T, Gjoni E, Altomare M, Rausei S. Conversion surgery for gastric cancer patients: A review. World J Gastrointest Oncol. 2018 Nov 15;10(11):398-409. doi: 10.4251/wjgo.v10.i11.398.
• Background Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.
• Results Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
• Results Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
• Results Al-Batran SE, Hofheinz RD, Pauligk C, Kopp HG, Haag GM, Luley KB, Meiler J, Homann N, Lorenzen S, Schmalenberg H, Probst S, Koenigsmann M, Egger M, Prasnikar N, Caca K, Trojan J, Martens UM, Block A, Fischbach W, Mahlberg R, Clemens M, Illerhaus G, Zirlik K, Behringer DM, Schmiegel W, Pohl M, Heike M, Ronellenfitsch U, Schuler M, Bechstein WO, Konigsrainer A, Gaiser T, Schirmacher P, Hozaeel W, Reichart A, Goetze TO, Sievert M, Jager E, Monig S, Tannapfel A. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial. Lancet Oncol. 2016 Dec;17(12):1697-1708. doi: 10.1016/S1470-2045(16)30531-9. Epub 2016 Oct 22.
• Results Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol. 2016 Jun;17(6):717-726. doi: 10.1016/S1470-2045(16)00175-3. Epub 2016 May 3.
• Results Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018 May 10;4(5):e180013. doi: 10.1001/jamaoncol.2018.0013. Epub 2018 May 10.
• Zhang Z, Lin Z, Xu Y, Luo L, Zeng H, Xiong W, Chen Y, Peng Y, Yang T, Zheng Y, Li J, Huang H, Wang W. Toripalimab combined with FLOT chemotherapy as conversion therapy for gastric cancer with peritoneal metastasis: a single-arm, open-label, phase II trial. BMC Cancer. 2025 Nov 8;25(1):1733. doi: 10.1186/s12885-025-15166-w.

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