Efficacy and safety of camrelizumab combined with FLOT versus FLOT alone as neoadjuvant therapy in patients with resectable locally advanced gastric and gastroesophageal junction adenocarcinoma who received D2 radical gastrectomy: Data update.

e16044 Background: Docetaxel-based neoadjuvant chemotherapy has been suggested to be beneficial in patients with locally advanced gastric and gastro-oesophageal junction cancer (GC/GEJC). And immunotherapy also show promising treatment efficacy for advanced GC/GEJC. Here we compared the safety and efficacy of camrelizumab combined with chemotherapy versus chemotherapy alone as the neoadjuvant therapy for patients with resectable locally advanced GC/GEJC. Methods: Eligible patients diagnosed as resectable locally advanced GC/GEJC were randomized to receive neoadjuvant treatment, in arm A, the patients received FLOT alone, in arm B, the patients received FLOT combined with camrelizumab(camrelizumab 200mg intravenously every 3 weeks). Eligible patients underwent gastrectomy with D2 lymph node dissection. The primary end point of this trial was pCR rate and R0 resection rate, and the secondary end points were ORR,PFS, OS and safety profile. Results: From January 15 2020 to January 15 2022, 61 patients were recruited (28 patients in arm A and 33 patients in arm B). 51 patients had completed planned neoadjuvant treatment for 4 cycles (25 pts in the arm A, 26 ptsin the arm B). Four patients in the arm A were failure to complete surgical treatment. This analysis was based on the 47 pts. In the arm A, the median age was 63 years (45-74 years) and a total of 16 males and 4 females, ECOG PS 0 (n = 3), ECOG PS 1 (n = 18). In the arm B, the median age was 63 years (28-72 years) and a total of 20 males and 6 females, ECOG PS 0 (n = 5), ECOG PS 1 (n = 21). The R0 resection rate was high in arm B compared with arm A (26/26,100% vs. 19/21, 90.5%). The same results are also reflected in pCR:arm B compared with arm A (3/26,11.5% vs. 1/21, 4.8%). Tumour regression grade were as follows:TRG0 [arm A 5% (1/21), arm B 15% (4/26)], TRG1 [arm A 10% (2/21), arm B 4% (1/26)], TRG2 [arm A 33% (7/21), arm B 54% (14/26)], TRG3 [arm A 52% (11/21), arm B 27% (7/26)].There was a greater proportion of postoperative stage ypN0 in arm B [arm A 24% (5/21); arm B 46% (12/26)]. Postoperative pathologic staging was as follows: ypT0 [arm A 5% (1/21); armB 15% (4/26)].ypT1 [arm A 14% (3/21); armB 8% (2/26)]. ypT2 [armA 0% (0/21); armB 27% (7/21)]. ypT3 [arm A 57% (12/21); arm B 38% (10/26)]. ypT4 [armA 24% (5/21); armB 12% (3/26)]. Neither serious intraoperative complications nor immune-related adverse events were observed during perioperation. Treatment-related AEs neutropenia and leukopenia were manageable and there was no treatment-related death. Conclusions: Camrelizumab combined with FLOT showed promising efficacy as neoadjuvant treatment for patients with locally advanced gastric or GEJ adenocarcinoma, with low complications and acceptable toxicity. Clinical trial information: ChiCTR2000030610.