The safety of laparoscopic D2 distal gastrectomy following neoadjuvant chemotherapy for locally advanced gastric cancer patients: a prospective multicenter trial (CLASS-03a)

Purpose: The objective of this study was to ascertain the safety of laparoscopic distal D2 radical gastrectomy in treating gastric cancer patients after NAC with locally advanced disease (cT3-4a, N0/ +, M0) by evaluating postoperative complications. Study Design: A prospective, multicenter, single-arm clinical trial. Methods: This clinical trial was conducted at 14 hospital centers in China. Adults aged 18–75 years with histologically confirmed LAGC (cT3-4a, N0/ +, M0) were enrolled in the study. Participants received three cycles of administration of intravenous oxaliplatin (130 mg/m 2 on day 1 of each cycle) plus oral capecitabine (1000 mg/m 2 twice daily on days 1 to 14 of each cycle), repeated every three weeks prior to undergoing laparoscopic distal gastrectomy. The primary endpoint was the postoperative overall morbidity rate. Secondary endpoints included postoperative mortality rate, surgery-related complications, R0 resection rate, and the rate of conversion to laparotomy, response of neoadjuvant chemotherapy (NAC), adverse event rate of NAC, operation time, blood loss, postoperative severe morbidity rate, and postoperative recovery course. Results: A total of 153 patients who underwent NAC prior to laparoscopic D2 distal gastrectomy were included in the final analysis. The study reported a postoperative overall morbidity rate of 20.9% (95%CI: 15.2%–28.0%), with a postoperative mortality rate of 0%. Pneumonia is the most common complication (9.2%). Ten patients exhibited elevated levels of body fluid amylase without presenting any clinical symptoms or undergoing additional clinical intervention. The R0 resection rate was achieved at 100%. The rate of conversion to laparotomy was 1.3%. 9.2% of patients achieved pathological complete response (pCR) following NAC. The overall incidence of adverse effects after NAC was 20.3% (95%CI: 14.7%–27.3%). The most common grade 3–4 treatment-related adverse events during neoadjuvant treatment were a decrease in platelet count and vomiting, each occurring in 0.7% of patients. Conclusion: The laparoscopic distal D2 radical gastrectomy demonstrated a favorable safety profile in the treatment of gastric cancer patients with advanced disease (cT3-4a, N0/ +, M0) following NAC.