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

BackgroundThe efficacy and safety of laparoscopic distal D2 radical gastrectomy for the treatment of locally advanced gastric cancer patients (LAGC) who have received neoadjuvant chemotherapy (NAC) is a topic of ongoing debate. 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, N-/+, M0).MethodsThis prospective, multicenter, single-arm clinical trial (ClinicalTrials.gov Identifiers: NCT03468712) was conducted at 14 hospital centers in China. Adults aged 18-75 years with histologically confirmed LAGC (cT3-4a, N-/+, M0) were enrolled in the study. Participants received 3 cycles of administration of intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus oral capecitabine (1000 mg/m2 twice daily on days 1 to 14 of each cycle) prior to undergoing laparoscopic distal gastrectomy. The primary endpoint was the postoperative overall morbidity rate. Secondary endpoints included postoperative mortality rate, surgery-related complication, R0 resection rate, completion rate of laparoscopic surgery, response of neoadjuvant chemotherapy, adverse event rate of neoadjuvant chemotherapy.ResultsA total of 153 patients were included in the final analysis. The study reported a postoperative overall morbidity rate of 20.9% (95%CI: 15.2%-28.0%), with postoperative mortality rate of 0%. Lung infections are the most common complication (9.2%). The surgery-related complication rate was 4.6% (95%CI: 2.2%-9.2%). Ten patients exhibited elevated levels of body fluid amylase without presenting any clinical symptoms or undergoing clinical intervention. The R0 resection rate occurred 100%. The completion rate of laparoscopic surgery was 98.7% (95%CI: 95.4%-99.6%). 9.2% patients achieved pathological complete response following NAC. The overall incidence of adverse effects after NAC was 20.3% (95%CI: 14.7%-27.3%).ConclusionsThe laparoscopic distal D2 radical gastrectomy demonstrated a favorable safety profile in the treatment of gastric cancer patients with advanced disease (cT3-4a, N-/+, M0) following neoadjuvant chemotherapy.Clinical trial identificationNCT03468712.Legal entity responsible for the studyK. Yang and Jianku Hu.Funding1. 3. 5 project for disciplines of excellence, West China Hospital, Sichuan University (No. ZYJC21006).DisclosureThe author has declared no conflicts of interest.