Efficacy and safety of camrelizumab combined with chemotherapy versus chemotherapy alone as preoperative neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma: Preliminary results from a multicenter, prospective, randomized controlled study.

4064 Background: Camrelizumab combined with chemotherapy has a very ideal therapeutic effect and low toxicity in the treatment of solid tumors. camrelizumab plays an important role in the treatment of locally advanced esophageal squamous cell carcinoma. Methods: This study is a prospective, multicenter, randomized controlled study. Inclusion criteria were patients aged 18-75 years with an ECOG score of 0-1 who had not received other treatments previously and had histologically confirmed resectable locally advanced esophageal squamous cell carcinoma (clinical stages cT1-4N1-3M0 and cT3-4N0M0). Patients received camrelizumab combined with chemotherapy (albumin paclitaxel + cisplatin in chemotherapy regimen) or chemotherapy alone (albumin paclitaxel + cisplatin in chemotherapy regimen). The primary endpoints are pathological complete remission (pCR) rate and 5-year overall survival (OS). Secondary endpoints including disease-free survival rate, duration of drug treatment and adverse events and we attempt to explore the correlation between drug efficacy and PD-L1 expression. The target sample size was 400 and patients were divided into two groups according to a 1:1 ratio who were received camrelizumab plus chemotherapy and chemotherapy alone. Results: From January 2021 to October 2022, 243 patients with resectable locally advanced esophageal squamous cell carcinoma from four centers were enrolled. Of these, 205 (85.2%) were male and 38 (15.6%) were female. Median age was 65 years. Most patients (182, 74.9%) were in clinical stage III and had an ECOG score of 1 (185, 76.1%). 150 patients had completed all clinical trial cycles and the result showed that among 90 patients who received camrelizumab plus chemotherapy, 25 patients achieved pathological complete remission(pCR), 39 achieved major partial remission (MPR), 11 had stable disease and 1 had progressive disease, with a pCR rate of 27.8% and MPR rate of 43.3%. Among 60 patients who received chemotherapy alone, 6 patients achieved pCR, 13 patients achieved MPR, 19 patients had stable disease and 2 patients had progressive disease, with a pCR rate of 10.0% and MPR rate of 26.7%. The most common adverse events were reactive cutaneous capillary endothelial proliferation (72.1%), nausea (42%), and leukopenia (15.5%), all of which were in grade 1 – 2 with manageable safety. Conclusions: Preliminary results of this study showed that the overall efficacy of camrelizumab plus chemotherapy was better than that of chemotherapy alone and the drug was safe and reliable. In future work, we will continue to analyze the survival outcomes, drug safety and the relationship between drug efficacy and PD-L1 expression and other biomarkers. Clinical trial information: ChiCTR2000040330 .