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 , Zhao Song , Wang Congcong 
Published: July 2024

e16122

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 190 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 Jan. 9th 2024, 121 pts (83 males and 38 females) with a median age of 65 years were enrolled in the study. One hundred and thirteen pts completed neoadjuvant treatment and 102 pts were available for imaging evaluation, the ORR was 91.9% and the DCR was 98.9%. Ninety six pts underwent surgery, 95 (98.9%) pts had a R0 resection, 32 (33.3%) pts reached pCR, 33 (34.3%) pts reached MPR. TNM down-staging was observed in 74 (77%) pts. Of 81 pts who underwent randomization, 30 pts reached pCR, 14 pts were randomly assigned to immunotherapy group, and 16 were assigned to BSC group. For 51 pts who did not reach pCR, 26 were randomized to the immunochemotherapy group and 25 were assigned to the immunotherapy group. At date cutoff, 5 pts (distant recurrence) relapsed in the immunochemotherapy group and 2 pts (distant recurrence) relapsed in the immunotherapy group who did not reach pCR. One hundred and twtety-one of 123 pts had AEs, and 33 pts had grade ≥3 AEs. The most common grade ≥3 AEs were anemia (9.9%), decreased lymphocyte count (7.4%), leukopenia (4.1%). 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 .