A randomized controlled study on perioperative treatment of esophageal squamous cell carcinoma with camrelizumab combined with nab-paclitaxel and cisplatin.
Authors: Qi Yu , Yang Yang , Li Weihao , Yue Songwei , Ma Yihui , Liu Donglei , He Zhanfeng , Chen Lidong , Li Wencai , Li Linghua , Zhao Song 
Published: June 2023

e16075

Background: Neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma (ESCC) has received increasing acceptance due to its effectiveness being confirmed by several phase II studies. CheckMate 577 has determined the efficacy of adjuvant immunotherapy in ESCC patients (pts) with R0 resection after neoadjuvant chemoradiotherapy. However, in the era of neoadjuvant immunotherapy, the optimal adjuvant treatment regimen for pts with ESCC warrant further research. This study aims to explore the efficacy and safety of perioperative treatment with camrelizumab combined with nab-paclitaxel and cisplatin for potentially resectable ESCC. Methods: This study planned to enroll 130 pts with potentially resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC. Eligible pts received 2-cycle of neoadjuvant camrelizumab (200mg, d1, q3w) combined with nab-paclitaxel (125mg/m2, d1,8, q3w) and cisplatin (75mg/m2, d1, q3w). Pts who reached pathologic complete remission (pCR) were randomly assigned to the immunotherapy group (camrelizumab for 16 cycles) and the best supportive care (BSC) group. Pts who did not reach pCR were randomly assigned to the immunochemotherapy group (camrelizumab combined with nab-paclitaxel and cisplatin for 2-4 cycles and camrelizumab for 12-14 cycles) and the immunotherapy group. Primary endpoints were pCR rate and 3-year DFS rate. Secondary endpoints were major pathologic response (MPR) rate, objective response rate (ORR), disease free survival (DFS), overall survival (OS). Results: As of Feb. 9th 2023, 72 pts (52 males and 20 females) with a median age of 64 years were enrolled in the study. Sixty-three pts completed neoadjuvant treatment and 54 pts were available for imaging evaluation, the ORR was 92.5% and the DCR was 98.1%. Fifty-three pts underwent surgery, 52 (98.1%) pts had a R0 resection, 19 (35.8%) pts reached pCR, 15 (28.3%) pts reached MPR. TNM down-staging was observed in 41 (77.3%) pts. Of 44 patients who underwent randomization, 16 pts reached pCR, 8 pts were randomly assigned to immunotherapy group and BSC group respectively. For pts who did not reach pCR, 15 were randomized to the immunochemotherapy group, and 13 were assigned to the immunotherapy group. The median follow-up was 6.1 months, and the median DFS had not yet reached. Sixty-eight out of 72 pts had AEs, and 25 pts had grade ≥3 AEs. The most common grade ≥ 3 AEs were anemia (9.7%), leukopenia (8.3%), hypokalemia (5.5%). There were 2 treatment-related deaths, one was due to postoperative complication and one due to bone marrow suppression, diarrhea and immunotherapy-related myocarditis. Conclusions: This ongoing study again confirmed the safety and efficacy of neoadjuvant immunochemotherapy for resectable ESCC. Further data on optimal adjuvant treatment regimen for pts with or without residual disease will be reported in the future. Clinical trial information: NCT05182944 .