Abstract 978P
Background
Definitive concurrent chemoradiotherapy (CCRT) is the standard treatment for patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). However, ESCC patients (pts) receiving CCRT are still unsatisfactory in terms of local control and overall survival (OS). The PACIFIC study has confirmed that consolidation immunotherapy with durvalumab significantly improves the progression-free survival (PFS) and OS. We conducted a clinical trial to evaluate the safety and efficacy of the camrelizumab (anti-PD-1) following definitive CCRT in pts with unresectable locally advanced ESCC, having hypothesized that consolidation with anti-PD-1 agents after CCRT could enhance the treatment efficacies.
Methods
This is a single-arm exploratory study to determine the safety and feasibility of this approach. camrelizumab was given intravenously over 30 min at a dose of 200 mg on day 1 of each 2-week cycle. Key eligibility criteria included as follows: pts diagnosed with inoperable locally advanced ESCC with 18-75 years old; pts with the clinical stage of Ⅱ-Ⅳa (T1bN+M0, T2-4N0-2M0); had received definitive concurrent chemoradiotherapy (50-60Gy with involved-field irradiation); ECOG performance status is 0-2; pts with measurable lesions (according to the criteria in RECIST1.1); and organ function is in the normal range. The primary end point was PFS.
Results
Eleven pts with ESCC were recruited between April 2020 and March 2021.The median follow-up time of pts was 6.9 months. Of them, 8 of 9 pts with stable disease. 1of 9 with progressive disease. The median PFS was not reached. The mean lung dose (MLD) and V20 of total lung was 1168.2Gy (range:838.2-1389.8Gy) and 23% (range:16-27%), respectively. The most common grade 1 or 2 adverse events included reactive cutaneous capillary endothelial proliferation (6/11), pneumonitis (4/11), hypothyroidism (1/11), hyperthyroidism (1/11), nausea (1/11), transfusion reaction (1/11). one patient had grade 3 transfusion reaction.
Conclusions
Camrelizumab is a well tolerated potential treatment option for ESCC patients who had received definitive concurrent chemoradiotherapy.
Clinical trial identification
NCT04286958.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.