Camrelizumab combined with concurrent chemoradiotherapy for locally recurrent esophageal cancer: A single-arm, open-label study.

Abstract

371 Background: Local recurrence is the main failure pattern after radical treatment of esophageal cancer. There is no uniform treatment specification for such patients(pts) so far. The combination of immune checkpoint inhibitors and concurrent chemoradiotherapy (CCRT) has emerged as a novel strategy to treat esophageal cancer. This research was to evaluate the efficacy and safety of camrelizumab (ICI targeting PD-1) combined with CCRT in the treatment of locally recurrent esophageal cancer. Methods: This open clinical study planned to enroll 62 pts with locally recurrent esophageal cancer following radical treatment who aged 18-75 years with ECOG performance status of 0-1. Pts received the following treatments: camrelizumab (200 mg q2w, continuous medication until disease progression, intolerable toxicity, or withdrawal); simultaneous radiotherapy (the total radiation dose was 50-50.4 Gy, which was given by 25-28 fractions, 5 fractions per week, with 1.8-2 Gy for each fraction); chemotherapy (capecitabine, 625mg/m2, bid, oral, d1-5, qw, total 5 weeks). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Results: Between Feb 2022 and Jul 2023, 14 pts with a median age of 71 years old had been enrolled. Among the evaluable pts, the ORR was 69.2% (9/13), the DCR was 100.0% (13/13). With a median follow-up of 16.0 months (95% CI 13.5-18.5), the median PFS was 7.6 months (95% CI 4.2–11.0), the median OS was 18.6 months (95% CI NE–37.6) in the full analysis set. The incidence of any grade adverse events (AEs) was 100.0% and that of grade ≥3 AEs was 57.1% of 14 pts. The most common AEs included lymphocyte count decreased (11/14, 78.6%), neutrophil count decreased (5/14, 35.7%), white blood cell count decreased (5/14, 35.7%) and anemia (5/14, 35.7%). The most grade ≥3 AE was lymphocyte count decreased (6/14, 42.9%). No new safety signals or treatment-related deaths were observed. Conclusions: Current results suggested the promising efficacy and acceptable safety of camrelizumab combined with CCRT in pts with locally recurrent esophageal cancer. The study enrollment is ongoing, and further survival and safety data will be reported in the future. Clinical trial information: NCT04390945 .