Abstract 48P
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 Nov 2024, 33 pts with a median age of 69 years old had been enrolled. Among the evaluable pts, the ORR was 59.3% (16/27), the DCR was 88.9% (24/27). With a median follow-up of 16.1 months (95% CI 5.3-26.8), the median PFS was 9.8 months (95% CI 5.7–14.5), the median OS had not yet reached in the full analysis set. The incidence of any grade adverse events(AEs) was 97.0% (32/33) and that of grade ≥3 AEs was 66.7% (22/33). The most common AEs included lymphocyte count decreased (28/33, 84.8%) and white blood cell count decreased (17/33, 51.5%). The most grade ≥3 AEs was lymphocyte count decreased (18/33, 54.5%) and white blood cell count decreased (4/33, 12.1%).
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 identification
NCT04390945.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.