Study of Envafolimab with Albumin-bound Paclitaxel and Carboplatin as Pre-Surgery Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of a combination treatment using Envafolimab, albumin-bound paclitaxel, and carboplatin as neoadjuvant therapy for patients with resectable locally advanced esophageal squamous cell carcinoma. This phase 2, single-center, prospective, single-arm study aims to understand how well this combined treatment works before surgery and its potential safety profile. Participants will receive Envafolimab via subcutaneous injection at 150mg on days 1, 8, and 15 of a 3-week treatment period followed by a 1-week rest. Along with Envafolimab, albumin-bound paclitaxel at 100 mgm2 and carboplatin at AUC 5 are given intravenously on the same schedule. This cycle is repeated twice over 8 weeks. After these two cycles, tumor status will be evaluated to determine if surgery is feasible. During the study, participants will be closely monitored for response through pathological complete response pCR rates, major pathological response, and overall response rate ORR. Further outcomes include R0 resection rate and three-year recurrence-free survival RFS and overall survival OS rates. Safety and treatment effects will be assessed up to 36 months. The total study duration includes active treatment and follow-up periods for long-term outcomes.

Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma