Abstract
BACKGROUND: This multicentre, open-label study evaluated the efficacy and safety of antiprogrammed death ligand 1 antibody SHR-1316 plus liposomal irinotecan and 5-fluorouracil as the first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC). METHODS: Eligible patients received SHR-1316 (10 mg/kg), liposomal irinotecan (60 mg/m(2) for the first cycle, 80 mg/m(2) thereafter), and 5-fluorouracil (2400 mg/m(2) ) every 14 days until disease progression, intolerable toxicity or withdrawal of consent. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. RESULTS: We enrolled 23 patients between 11 March 2019 and 31 May 2019. The median follow-up duration was 15.2 months (95% CI 14.2-16.2). The median PFS was 8.5 months (95% CI 1.2-15.8), and ORR and DCR were 52.2% (95% CI 30.1-74.3) and 73.9% (95% CI 54.5-93.3), respectively. The median OS was 11.6 months (95% CI 6.7-16.6). The most common treatment-related grade 3-4 adverse events (AEs) were neutropenia (17.4%), nausea (13.0%), and anorexia (13.0%). Treatment-related serious AEs occurred in two patients. No treatment-related deaths occurred. CONCLUSIONS: SHR-1316 plus liposomal irinotecan and 5-fluorouracil has a promising efficacy and manageable safety profile, and could be a new first-line treatment approach for patients with unresectable locally advanced or distant metastatic ESCC.