Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer.

多西他赛、奥沙利铂、氟尿嘧啶和亚叶酸的新辅助化疗（FLOT方案）在局部晚期可切除胃癌（LAGC）患者的病理反应和生存率方面显示出有希望的结果。然而，替加氟吉美拉西钾胶囊（S-1）加奥沙利铂（SOX方案）是东方国家的首选化疗方案。在这里，我们进行了一项开放标签、双臂、II 期随机介入临床试验（Dragon III；ClinicalTrials.gov：NCT03636893），以评估两种方案的安全性和有效性。 LAGC 患者在胃切除术前被随机分配接受 4 个周期的新辅助 FLOT 方案（40 名患者）或 3 个周期的 SOX 方案（34 名患者）。主要终点是原发肿瘤的完整（TRG1a）或次全（TRG1b）肿瘤消退分级的比较。两组之间的不良反应或术后发病率和死亡率没有显着差异。 FLOT组与SOX组肿瘤消退分级比例无显着差异。 FLOT 组的完整或小计 TRG 为 20.0%，而 SOX 组为 32.4%。因此，我们的研究没有发现新辅助 FLOT 和 SOX 方案在局部进展期胃癌的主要结局方面存在统计学上的显着差异。