Recent efficacy and safety analysis of neoadjuvant therapy with Tislelizumab combined with Apatinib and chemotherapy in Borrmann type IV, large Borrmann type III, and Bulky N locally advanced gastric cancer(3-B).

Abstract Background To explore the efficacy and safety of immune checkpoint inhibitor Tislelizumab combined with Apatinib and chemotherapy in the neoadjuvant therapy of Borrmann IV, large Borrmann III and Bulky N locally advanced gastric cancer. Methods Patients with untreated, Her-2-negative, resectable locally advanced gastric adenocarcinoma (Borrmann IV, large Borrmann III, and Bulky N) were enrolled. Preoperative neoadjuvant therapy with tirelizumab combined with apatinib and SOX regimen was performed for 3 to 6 cycles. 3 cycles of evaluation, if PR, surgery; if SD, continue neoadjuvant therapy, after 6 cycles of re-evaluation of surgery. Results Forty patients were recruited, large Borrmann III in 26 cases, Borrmann IV in 6 cases, and Bulky N in 8 cases. The results of the radiographic evaluation were as follows: PR in 36 cases (90%), SD in 3 cases, PD in 1 case, and ORR rate was 90%. All patients underwent D2 or D2 + surgery, including R0 resection in 37 cases and R2 resection in 2 cases. Pathological effects: ypCR (TRG0) in 7 cases (17.9%), TRG1 in 9 cases, TRG2 in 18 cases, TRG3 in 5 cases. The MPR rate was 40.0%. Grade 3 to 4 adverse reactions occurred in 19 patients (47.5%) during neoadjuvant therapy. The incidence of postoperative complications was 33.3%, and grade IIIA or above was 7.7%, no perioperative death occurred. Conclusion For Borrmann IV, large Borrmann III, and Bulky N-positive, locally advanced gastric cancer, the triple regimen of Tislelizumab combined with Apatinib and chemotherapy can achieve clinical benefit with acceptable safety. Clinical Trial Registration: Registered with ClinicalTrials.gov, registration number NCT05223088.