对于胃癌 (GC) 腹膜转移 (PM) 患者，化疗是首选治疗方法。细胞减灭手术（CRS）和腹腔热灌注化疗（HIPEC）仍在争论中。这项随机、对照、开放标签、多中心 III 期试验（EudraCT 2006-006088-22；ClinicalTrials.gov 标识符：NCT02158988）探讨了 CRS 后 HIPEC 对总生存期 (OS) 的影响。患有 GC 和组织学证明 PM 的成年患者随机分配 (1:1) 接受围手术期化疗和单独 CRS (CRS-A) 或 CRS 加 HIPEC (CRS H)。 HIPEC 包含丝裂霉素 C 15 mg/m2 和顺铂 75 mg/m2，溶于 5 L 盐水中，在 42°C 下灌注 60 分钟。主要终点是 OS；次要终点包括无进展生存期（PFS）、其他无远处转移生存期（MFS）和安全性。分析遵循意向治疗原则。2014年3月至2018年6月期间，105名患者被随机分配（53名患者接受CRS-A，52名患者接受CRS H）。由于招募缓慢，试验提前停止。 55 名患者在 CRS 之前停止治疗，主要是由于疾病进展/死亡。两组的中位 OS 相同（CRS H，14.9 [97.2% CI，8.7 至 17.7] 个月 vs CRS-A，14.9 [97.2% CI，7.0 至 19.4] 个月；P = .1647）。 CRS-A 组的 PFS 为 3.5 个月（95% CI，3.0 至 7.0），CRS H 组的 PFS 为 7.1 个月（95% CI，3.7 至 10.5；P = 0.047）。 CRS H 组表现出更好的 MFS（10.2 个月 [95% CI，7.7 至 14.7]，而 CRS-A 组为 9.2 个月 [95% CI，6.8 至 11.5]；P = .0286）。各组间 ≥3 级不良事件 (AE) 的发生率相似（CRS-A，38.1% vs CRS H，43.6%；P = .79）。本研究显示 CRS H 和 CRS-A 之间的 OS 没有差异。 CRS H组的PFS和MFS明显更好，这需要进一步探索。 HIPEC 并未增加 AE。

In patients with peritoneal metastasis (PM) from gastric cancer (GC), chemotherapy is the treatment of choice. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are still being debated. This randomized, controlled, open-label, multicenter phase III trial (EudraCT 2006-006088-22; ClinicalTrials.gov identifier: NCT02158988) explored the impact on overall survival (OS) of HIPEC after CRS.Adult patients with GC and histologically proven PM were randomly assigned (1:1) to perioperative chemotherapy and CRS alone (CRS-A) or CRS plus HIPEC (CRS + H). HIPEC comprised mitomycin C 15 mg/m2 and cisplatin 75 mg/m2 in 5 L of saline perfused for 60 minutes at 42°C. The primary end point was OS; secondary endpoints included progression-free survival (PFS), other distant metastasis-free survival (MFS), and safety. Analyses followed the intention-to-treat principle.Between March 2014 and June 2018, 105 patients were randomly assigned (53 patients to CRS-A and 52 patients to CRS + H). The trial stopped prematurely because of slow recruitment. In 55 patients, treatment stopped before CRS mainly due to disease progression/death. Median OS was the same for both groups (CRS + H, 14.9 [97.2% CI, 8.7 to 17.7] months v CRS-A, 14.9 [97.2% CI, 7.0 to 19.4] months; P = .1647). The PFS was 3.5 months (95% CI, 3.0 to 7.0) in the CRS-A group and 7.1 months (95% CI, 3.7 to 10.5; P = .047) in the CRS + H group. The CRS + H group showed better MFS (10.2 months [95% CI, 7.7 to 14.7] v CRS-A, 9.2 months [95% CI, 6.8 to 11.5]; P = .0286). The incidence of grade ≥3 adverse events (AEs) was similar between groups (CRS-A, 38.1% v CRS + H, 43.6%; P = .79).This study showed no OS difference between CRS + H and CRS-A. PFS and MFS were significantly better in the CRS + H group, which needs further exploration. HIPEC did not increase AEs.