Multicenter, single-arm, phase II trial of camrelizumab and chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma

• DOI: 10.1136/jitc-2021-004291
• Publication Date: 2022-03-25T16:35:36Z
• Authors: Jun Liu; Yang Yang; Zhichao Liu; Xiaolong Fu; Xiaoyue Cai; Hongxuan Li; Li Zhu; Yan Shen; Hong Zhang; Yifeng Sun; Hezhong Chen; Bentong Yu; Renquan Zhang; Jinchen Shao; Ming Zhang; Zhigang Li
• Keywords: Carboplatin; Clinical endpoint; Neoadjuvant Therapy

Camrelizumab and chemotherapy demonstrated durable antitumor activity with a manageable safety profile as first-line treatment in patients advanced esophageal squamous cell carcinoma (ESCC). This study aimed to evaluate the efficacy of camrelizumab plus neoadjuvant chemotherapy, using pathologically complete response (pCR) primary endpoint, for locally ESCC.Patients but resectable thoracic ESCC, staged T1b-4a, N2-3 (≥3 stations), M0 or M1 lymph node metastasis (confined supraclavicular nodes) were enrolled. Eligible received intravenous (200 mg, day 1) nab-paclitaxel (100 mg/m2, 1, 8, 15) carboplatin (area under curve 5 mg/mL/min, each 21-days cycle, two cycles before surgery. The endpoint is pCR rate per-protocol population. Safety was assessed modified intention-to-treat population that treated at least one dose camrelizumab.From November 20, 2019 December 22, 2020, 60 55 (91.7%) completed full two-cycle successfully. 51 underwent surgery R0 resection achieved 50 (98.0%) patients. (ypT0N0) identified 20 (39.2%) (9.8%) had tumor residual disease nodes alone (ypT0N+). 58 (96.7%) any-grade treatment-related adverse events (TRAEs), most common being leukocytopenia (86.7%). 34 (56.7%) grade 3 worse, patient (1.7%) occurred event. There no in-hospital postoperative 30-day well 90-day mortality.The robust confirmed without unexpected signals. Our findings established promising ESCC.ChiCTR1900026240.