The efficacy and safety of neoadjuvant sintilimab combined with chemotherapy in resectable locally advanced lymph node-positive esophageal squamous cell carcinoma: A real world study.

e16091 Background: Many phase III clinical trials (Keynote 590, Orient 15, etc) have all proved the role of immunotherapy combined with chemotherapy in the treatment of esophageal squamous cell carcinoma. This study was designed to evaluate the efficacy and safety of immunotherapy and chemotherapy as neoadjuvant therapy for resectable locally advanced lymph node-positive esophageal squamous cell carcinoma. Methods: This is a multicenter, 2-cohort (IO+CT group & CRT group), real world study. In IO+CT group, patients(pts) will receive sintilimab 200 mg once on day 1, albumin-bound paclitaxel 260g/m 2 from day 1 to 4, carboplatin 80mg/m 2 on day 1, every 21 days(Q3W) for 2 cycles. Key eligibility criteria included resectable, locally advanced lymph node-positive esophageal squamous cell carcinoma conformed by histology, and aged ≥18 years old with ECOG PS 0-1. The primary endpoint was pathologic complete response (pCR) rate. The secondary endpoints were event free survival (EFS), objective response rate (ORR), overall survival (OS) and safety. Results: From 7/2022 to 9/2023, 30 pts were enrolled in IO+CT group. In IO+CT group, among 30 pts who underwent surgery, 9 (30%) achieved pCR. 93.3% pts (28/30) achieved R0 resection. In 20 evaluable pts, 3(15%) achieved complete response (CR), 15(75%) achieved partial response (PR), 2(10%) achieved stable disease (SD). ORR and DCR were 90.0% (18/20) and 100.0% (20/20), respectively. There were no grade ≥2 treatment-related adverse events (TRAEs) appeared. The most common grade 1 TRAEs was fatigue (13.3%). Conclusions: In the real world, sintilimab plus chemotherapy used as neoadjuvant therapy in resectable locally advanced lymph node-positive esophageal squamous cell carcinoma could be effective and manageable toxicity. Clinical trial information: ChiCTR2200058565.