Neoadjuvant therapy of camrelizumab combined with chemotherapy in patients (pts) with resectable esophageal squamous cell cancer (ESCC): A single-center, single-arm, exploratory clinical trial.

person Ji chen Yang The Affifiliated Hospital of Qingdao University, Qingdao, Shandong, China info_outline Ji chen Yang, Wenjie Jiao, Feng Hua, Xiaoming Zhao, Wenfeng Yang

Authors person Ji chen Yang The Affifiliated Hospital of Qingdao University, Qingdao, Shandong, China info_outline Ji chen Yang, Wenjie Jiao, Feng Hua, Xiaoming Zhao, Wenfeng Yang Organizations The Affifiliated Hospital of Qingdao University, Qingdao, Shandong, China, Affiliated Hospital of Qingdao University, Qingdao, China, Shandong Cancer Hospital and Institute, Jinan, Shandong, China Abstract Disclosures Research Funding No funding sources reported Background: The study aimed to evaluate the efficacy and safety of neoadjuvant therapy of camrelizumab, combined with chemotherapy in resectable ESCC pts and explore factors related to efficacy. Methods: Patient with resectable ESCC, staged as cT1b-cT2N+ or cT3-cT4aNany were enrolled. Eligible pts received camrelizumab (200 mg, d1) combined with nab-paclitaxel (200 mg/m 2 , d1) and nedaplatin (75 mg/m 2 , administered on an average of two days) and S-1 (50mg/m 2 , bid, d1-14) for 2 or 3 cycles (21 days per cycle) before surgery. The primary endpoints were pathological complete response (pCR) rate. Results: From Aug 25, 2022, to Nov 17, 2023, a total of 53 pts were enrolled in this study and completed 2 or 3-cycle neoadjuvant therapy. Median age was 58(54-63), 47 males and 6 females, The primary site was upper segment in 3 pts, middle segment in 27 pts, and lower segment in 23 pts, The clinical T staging was T2 in 2 pts, T3 in 49 pts, and T4 in 2 pts. The clinical N staging was N0 in 8 pts, N1 in 28 pts, N2 in 16 pts, and N3 in 1 pt. The physical condition score was 0 for 16 pts, and 1 for 27 pts. 37 pts underwent surgery and R0 recetion was achieved in 37 (100%) pts. pCR(ypT0N0) was identified in 9(24.3%) and 3(8.1%) pts had conplete response of primary tumor but residual didease in lymph nodes alone (ypT0N+), the MPR was was identified in 5(13.5%) pts. Of pts who underwent surgery, 25(67.6%) received 3-cycle and 12(32.4%) received 2-cycle neoadjuvant therapy, the pCR rate was 32% and 8.3%,respectively. According to tumor regression grade, 12 (11(44%) in 3-cycle and 1(8.3%) in 2-cycle) pts had TRG0, 5(4(16%) in 3-cycle and 1(8.3%) in 2-cycle) TRG1, 15 (9(36%) in 3-cycle and 6(50%) in 2-cycle) TRG2, and 4 (all 4(33.3%) in 2-cycle) TRG3. Also we found there was no relationship between the NK cells, B cells, total T lymphocytes, Th cells, Tc/Ts cells, CD4+/CD8+ratio and the pCR and MPR rate. The most common AEs were anemia (71.7%)、 lymphocyte count decreased (67.9%)、white blood cell count decreased (52.8%) and neutrophil count decreased (52.8%). Most AEs were grade 1-2. No grade 4/5 AEs occurred. Conclusions: The short-term efficacy and safety of camrelizumab combined with three drugs chemotherapy were similar to previous research combined with two drugs.The efficacy of three-cycle regimen seems to be significantly better than the two-cycle regimen, which may indicate that the two-cycle neoadjuvant therapy is still insufficient, and confirmatory results need to be verified through large-scale clinical studies. Clinical trial information: ChiCTR2300068185 .

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