Hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally advanced gastric cancer after D2 radical resection: a randomized controlled study

Background: Currently, there is a lack of effective strategy for the prevention of peritoneal metastasis(PM) from locally advanced gastric cancer (AGC). This randomized controlled study aimed to evaluate the outcome of D2 radical resection with hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally AGC patients. Methods: : All patients enrolled were randomly assigned to receive HIPEC plus systemic chemotherapy (HIPEC group) or systemic chemotherapy alone (non-HIPEC group) after radical gastrectomy. HIPEC was performed intraperitoneally with cisplatin (40 mg/m 2 ) within 72h after surgery, while systemic chemotherapy based on SOX regimen (S-1 combined with oxaliplatin) was administered 4-6 weeks after radical surgery. Patterns of recurrence, adverse events, 3-year disease-free survival (DFS) and overall survival (OS) were analyzed. Results: : A total of 134 patients were enrolled in the present study. The 3-year DFS rate was 73.8% in the HIPEC group, which was significantly higher than that in the non-HIPEC group (61.2%, P=0.031). The 3-year OS rate was 73.9% in the HIPEC group and 77.6% in the non-HIPEC group, with no significant difference (P = 0.737). PM was the most common distant metastasis in both groups. The occurrence rate of PM in the HIPEC group was statistically lower than that in the non-HIPEC group (20.9% vs. 40.3%, P=0.015). Grade 3 or 4 adverse events were occurred in 19 (14.2%) patients, and there was no statistic difference between the two groups. Conclusion: Radical surgery followed by HIPEC combined with systemic chemotherapy is a safe and feasible strategy for locally AGC patients and could effectively improve the DFS and reduce the occurrence of PM. However, more prospective randomized studies with a large sample size are warranted. Trial registration: This study was registered with www.medresman.org.cn as ChiCTR2200055966 on 30/01/2022.