Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E)
Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E)
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DOI：
10.2217/fon-2020-0189
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发表时间：
2020-07-01
期刊：
影响因子：
3.3
通讯作者：
Kitagawa, Yuko
中科院分区：
文献类型：
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作者：
Yamamoto, Shun;Kato, Ken;Kitagawa, Yuko
可切除的食管鳞癌(ESCC)的标准治疗方法之一是先进行新辅助化疗，然后进行手术。尼伏单抗对转移性食管癌有效。然而，新辅助剂nivolumab联合化疗治疗ESCC的安全性和有效性尚不清楚。因此，我们将对新辅助化疗中应用尼伏单抗的安全性和有效性进行前沿评价。FronTier包括四个实验队列：(A)包括nivolumab加5-FU+CDDP(顺铂和5-氟尿嘧啶[CF])；(B)包括一次先前给予nivolumab和队列A方案；(C)包括nivolumab加多西紫杉醇+CF；(D)包括一次先前给予nivolumab和队列C方案；扩大队列。主要终点是从最初的剂量到术后第30天的剂量限制毒性的发生率。临床试验标识：NCT03914443
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. Clinical Trial Identifier: NCT03914443