Purpose A phase II study was conducted to evaluate the safety and efficacy of preoperative, intra-arterial perfusion of epirubicin, etoposide, and oxaliplatin combined with oral chemotherapy S-1 (SEEOX) for the treatment of type 4 gastric cancer. Materials and Methods A single-center, single-arm phase II trial was conducted on 36 patients with histologically proven type 4 gastric cancer without distant peritoneal or organ metastasis. Patients received 3, 21-day courses of SEEOX preoperative chemotherapy. The primary endpoint was overall survival (OS) and the secondary outcomes assessed were chemotherapeutic response, radical resection rate, pathological regression, toxicities, postoperative morbidity, and mortality. Results All patients were at an advanced stage of cancer (stage III or IV) and completed the entire course of treatment. Based on changes in tumor volume and peritoneal metastasis, the objective response rate was 55.6% (20/36; 95% confidence interval [CI], 38.5%–72.6%) and the disease control rate was 69.4% (25/36; 95% CI, 53.6%–85.3%). The radical resection rate was 75% (27/36; 95% CI, 60.1%–89.9%) and the proportion of R0 resections was 66.7% (21/36; 95% CI, 50.5%–82.8%). The pathological response rate was 33.3%, of which 13.9% showed complete pathological regression. The median survival was 27.1 months (95% CI, 22.24–31.97 months), and the 2-year OS was 48.5% (95% CI, 30.86%–66.1%). Conclusions Preoperative SEEOX is a safe and effective treatment for type 4 gastric cancer. Based on these preliminary data, a phase III study will be conducted to confirm the superiority of this regimen over standard treatment. Trial Registration ClinicalTrials.gov Identifier: NCT02949258

中文翻译：

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术前动脉内表柔比星、依托泊苷、奥沙利铂联合口服S-1化疗治疗Borrmann 4型胃癌的II期研究

目的进行一项II期研究，评估表柔比星、依托泊苷和奥沙利铂联合口服化疗S-1（SEEOX）术前动脉内灌注治疗4型胃癌的安全性和有效性。材料和方法 对 36 名经组织学证实无远处腹膜或器官转移的 4 型胃癌患者进行了一项单中心、单臂 II 期试验。患者接受了 3 个 21 天的 SEEOX 术前化疗疗程。主要终点是总生存期（OS），评估的次要结局是化疗反应、根治性切除率、病理消退、毒性、术后发病率和死亡率。结果所有患者均处于癌症晚期（III期或IV期）并完成整个治疗过程。根据肿瘤体积和腹膜转移的变化，客观缓解率为 55.6%（20/36；95% 置信区间 [CI]，38.5%~72.6%），疾病控制率为 69.4%（25/36；95 % CI，53.6%–85.3%）。根治性切除率为75%（27/36；95% CI，60.1%~89.9%），R0切除比例为66.7%（21/36；95% CI，50.5%~82.8%）。病理缓解率为33.3%，其中病理完全消退率为13.9%。中位生存期为 27.1 个月（95% CI，22.24-31.97 个月），2 年 OS 为 48.5%（95% CI，30.86%-66.1%）。结论术前SEEOX治疗4型胃癌安全、有效。基于这些初步数据，将进行一项 III 期研究，以确认该方案优于标准治疗。试验注册 ClinicalTrials.gov 标识符：