AbstractBackgroundDespite growing trends of neoadjuvant chemotherapy for advanced gastric cancer, there is still no consensus of optimal regimens between East and West countries. Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and Leucovorin (FLOT) regimen has shown promising results in terms of pathological response and survival rate. However, S-1 plus oxaliplatin (SOX) is a more favorable chemotherapy regimen in Eastern countries. We conducted this study to evaluate the safety and efficacy of both regimens, and to explore a suitable regimen for Chinese patients.MethodsPatients with locally advanced gastric cancer(LAGC) were 1:1 randomly assigned to receive either 4 cycles of FLOT or 3 cycles of SOX regimen before curative gastrectomy. The primary endpoint was the comparison of complete or sub-total tumor regression grading (TRG1a+ TRG1b) in the primary tumor.ResultsAltogether 74 cases enrolled between August 2018 and March 2020. All 74 randomly assigned cases were considered as intention-to-treat (ITT) population, and the 55 patients who completed the planned chemotherapy plus surgery were considered as per protocol (PP) population. There was no significant difference in pre-treatment clinicopathological parameters between the FLOT and SOX group(p>0.05). There was no significant difference in adverse effects or postoperative morbidity and mortality between two groups (p>0.05). Similarly, there was no significant difference in the proportion of tumor regression grading between the FLOT and SOX group(p>0.05). In the ITT population, complete or sub-total TRG was 20.0 % in FLOT versus 32.4 % in the SOX group (p>0.05).ConclusionsOur study demonstrates that FLOT and SOX regimens are similarly effective for locally advanced gastric cancer patients in terms of clinical downstaging and pathological response. Both regimens were well-tolerated in this study. A large scale phase 3 randomized controlled trial is necessary to validate this result.