Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer

Summary

This study aims to evaluate the effectiveness and safety of a preoperative treatment (called neoadjuvant therapy) combining four drugs-nab-paclitaxel, oxaliplatin, S-1, and sintilimab-for patients with locally advanced, resectable early-onset gastric cancer (diagnosed at age 45 or younger). All participants will receive this drug combination before undergoing surgery to remove the tumor. The goal is to shrink the tumor, increase the chance of complete surgical removal, and improve long-term outcomes. This is a single-arm, open-label, phase II clinical trial, meaning all participants will receive the same treatment, and both doctors and patients will know what drugs are being used. The study is being conducted at Peking University People's Hospital.

Timeline

Start

2025-10-01

Primary completion

2027-12-30

Completion

2030-06-01

Publications

• Background Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Background Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H. Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer. 2003 Oct 1;98(7):1521-30. doi: 10.1002/cncr.11660.
• Background Watson S, de la Fouchardiere C, Kim S, Cohen R, Bachet JB, Tournigand C, Ferraz JM, Lefevre M, Colin D, Svrcek M, Meurisse A, Louvet C. Oxaliplatin, 5-Fluorouracil and Nab-paclitaxel as perioperative regimen in patients with resectable gastric adenocarcinoma: A GERCOR phase II study (FOXAGAST). Eur J Cancer. 2019 Jan;107:46-52. doi: 10.1016/j.ejca.2018.11.006. Epub 2018 Dec 7.
• Background Shitara K, Takashima A, Fujitani K, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Makari Y, Amagai K, Ueda S, Yoshida K, Shimodaira H, Nishina T, Tsuda M, Kurokawa Y, Tamura T, Sasaki Y, Morita S, Koizumi W. Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):277-287. doi: 10.1016/S2468-1253(16)30219-9. Epub 2017 Jan 19.
• Background Zhang C, Tang R, Zhu H, Ge X, Wang Y, Wang X, Miao L. Comparison of treatment strategies and survival of early-onset gastric cancer: a population-based study. Sci Rep. 2022 Apr 15;12(1):6288. doi: 10.1038/s41598-022-10156-5.
• Background Liu L, Lin J, Zhao J, Yan P. Analysis of clinicopathologic characteristics and prognosis of gastric cancer in patients <40 years. Medicine (Baltimore). 2023 Aug 25;102(34):e34635. doi: 10.1097/MD.0000000000034635.
• Background Liu JD, Ye BT, Fu M, Zhang Q, Chen H, Sun J, Cai TY, Wang ZM, He HY, Zhao JJ, Li HJ, Wang XF, Sun YH. [Clinicopathological and molecular diagnostic features of early-onset gastric cancer: a study based on data from a single-center dedicated gastric cancer database]. Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Oct 25;26(10):963-967. doi: 10.3760/cma.j.cn441530-20230603-00190. Chinese.
• Background Pocurull A, Herrera-Pariente C, Carballal S, Llach J, Sanchez A, Carot L, Botargues JM, Cuatrecasas M, Ocana T, Balaguer F, Bujanda L, Moreira L. Clinical, Molecular and Genetic Characteristics of Early Onset Gastric Cancer: Analysis of a Large Multicenter Study. Cancers (Basel). 2021 Jun 23;13(13):3132. doi: 10.3390/cancers13133132.
• Background Rompen IF, Nienhuser H, Crnovrsanin N, Musa J, Haag GM, Longerich T, Fiedler T, Muller-Stich BP, Sisic L, Billeter AT. Clinical Characteristics and Oncological Outcomes of Surgically Treated Early-Onset Gastric Adenocarcinoma - a Retrospective Cohort Study. J Cancer. 2023 May 21;14(9):1470-1478. doi: 10.7150/jca.82876. eCollection 2023.
• Background Qu X, Zhao X, Liu Y, Wang N, Zhang L, Zhu X, Dong Q, Liu J, Shi Y. The clinicopathological characteristics of early-onset gastric cancer and its evolutionary trends: a retrospective study. Am J Cancer Res. 2022 Jun 15;12(6):2757-2769. eCollection 2022.
• Background Ning FL, Zhang NN, Zhao ZM, Du WY, Zeng YJ, Abe M, Pei JP, Zhang CD. Global, Regional, and National Burdens with Temporal Trends of Early-, Intermediate-, and Later-Onset Gastric Cancer from 1990 to 2019 and Predictions up to 2035. Cancers (Basel). 2022 Nov 3;14(21):5417. doi: 10.3390/cancers14215417.
• Background Lumish MA, Walch H, Maron SB, Chatila W, Kemel Y, Maio A, Ku GY, Ilson DH, Won E, Li J, Joshi SS, Gu P, Schattner MA, Laszkowska M, Gerdes H, Jones DR, Sihag S, Coit DG, Tang LH, Strong VE, Molena D, Stadler ZK, Schultz N, Janjigian YY, Cercek A. Clinical and molecular characteristics of early-onset vs average-onset esophagogastric cancer. J Natl Cancer Inst. 2024 Feb 8;116(2):299-308. doi: 10.1093/jnci/djad186.

Drugs

Indications