Head & Neck Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
Department of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Future Oncol. 2020 Jul;16(19):1351-1357. doi: 10.2217/fon-2020-0189. Epub 2020 May 12.
One of the standard treatments of resectable esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemotherapy followed by surgery. Nivolumab showed efficacy for metastatic ESCC. However, the safety and efficacy of neoadjuvant nivolumab with chemotherapy for ESCC is unknown. Therefore, we will conduct FRONTiER to evaluate the safety and efficacy of nivolumab adding to neoadjuvant chemotherapy. FRONTiER comprises four experimental cohorts: (A) including nivolumab plus 5-FU+CDDP (cisplatin and 5-fluorouracil [CF]); (B) including one prior administration of nivolumab and the cohort A regimen; (C) including nivolumab plus docetaxel+ CF; (D) including one prior administration of nivolumab and the cohort C regimen; an expanded cohort. The primary end point is the incidence of dose-limiting toxicities from the initial dose to the 30th postoperative day. NCT03914443.
可切除食管鳞癌（ESCC）的标准治疗之一是新辅助化疗后手术。纳武利尤单抗对转移性 ESCC 有效。然而，纳武利尤单抗联合化疗新辅助治疗 ESCC 的安全性和有效性尚不清楚。因此，我们将开展 FRONTiER 研究评估纳武利尤单抗联合新辅助化疗的安全性和有效性。FRONTiER 包括四个实验组：（A）包括纳武利尤单抗联合 5-FU+CDDP（顺铂和氟尿嘧啶[CF]）；（B）包括一次纳武利尤单抗给药和 A 组方案；（C）包括纳武利尤单抗联合多西他赛+CF；（D）包括一次纳武利尤单抗给药和 C 组方案；扩展组。主要终点是从初始剂量到术后第 30 天的剂量限制性毒性发生率。NCT03914443。
