Phase 2 study of preoperative conversion therapy of camrelizumab with paclitaxel and nedaplatin for unresectable advanced ESCC

Patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) have limited treatment options and poor outcomes. A phase 2 study at Harbin Medical University (Heilongjiang, China) evaluated conversion therapy with camrelizumab (anti-PD-1) plus paclitaxel and nedaplatin chemotherapy every 3 weeks for unresectable ESCC (132 patients locally advanced [M0]; 9 patients metastatic [M1]). An efficacy assessment was performed every two cycles; patients considered to have resectable disease underwent surgery 4-6 weeks after the last dose. The median duration of follow-up was 32.2 months. Post-induction ORR was 56.7%. The ITT conversion rate was 48.9% overall and 50.0% in M0 patients (R0: 100%; pCR: 20.9%; major pathological response; 55.2%). One-year overall survival was 78.7%. Surgical conversion significantly improved overall survival (median not reached versus 14.1 months; HR 0.22; p<0.0001), with further benefit in objective responders (median not reached versus 20.9 months; HR 0.30; p<0.001). Approximately 75% of patients experienced treatment-related adverse events, predominantly mild to moderate. The authors conclude that this regimen showed promising efficacy as a conversion therapy for unresectable advanced ESCC.