Hyperthermic intraperitoneal chemotherapy (HIPEC) has a unique effect on the prevention and treatment of peritoneal metastasis from malignancies. Recently, the first prospective, multicenter, randomized controlled clinical trial of HIPEC to prevent the development of peritoneal metastasis after curative surgery for patients with locally advanced colon cancer was published in the "Lancet Gastroenterol Hepatol" (COLOPEC). Regrettably, no significant difference was observed in 18-month peritoneal metastasis-free survival between postoperative adjuvant HIPEC and standard systemic chemotherapy for patients with T4 stage or perforated colon cancer. However, we wonder whether we might achieve better outcomes by further optimizing the following issues: (1) We propose that the inclusion criteria for that trial may not be entirely reasonable, which included pT4N0-2M0 and perforation. Additionally, we found that 91% of patients underwent HIPEC 5-8 weeks after primary tumor resection. (2) The imbalance in starting time of postoperative systemic chemotherapy between the two groups may have a negative impact.(3) Nine patients with peritoneal metastasis preceding HIPEC might weaken the potential efficacy of HIPEC. (4) We wonder whether HIPEC using high-dese oxaliplatin (460 mg/m(2)) perfusing 30 minutes for one cycle is the optimal regimen. Therefore, we are planning to conduct a randomized controlled trial (HIPEC-06) in accordcance with the characteristics of Chinese patients, to explore the clinical efficacy of curative surgery combined with HIPEC in the treatment of cT4 colorectal cancer.
腹腔热灌注化疗（HIPEC）对预防和治疗恶性肿瘤的腹膜种植转移具有独特疗效。最近，"Lancet Gastroenterol Hepatol"报道了国际上首个HIPEC用于局部进展期结肠癌患者根治术后预防腹膜转移的前瞻性、多中心、随机对照临床试验COLOPEC，遗憾的是，该研究为阴性结果，对于T(4)期或伴有穿孔结肠癌患者，结果发现与单纯接受根治手术后常规静脉化疗相比，额外增加1次HIPEC治疗并没有改善患者术后18个月无腹膜转移生存率。针对该研究报道，本团队对这篇文献进行反复学习、讨论后，认为该研究设计、特别是HIPEC方案上仍存在一定的争议，主要包括：（1）入组标准中纳入pT(4)N(0~2)M(0)或穿孔性结肠癌患者可能并不完全合理，91%的患者均在原发性肿瘤切除5~8周后才接受辅助HIPEC治疗。（2）两组间术后静脉化疗开始时间不均衡。（3）在HIPEC组中，实际上有9例患者在术后5~8周进行HIPEC治疗之前已经发生了腹膜转移。（4）1次30 min大剂量奥沙利铂（460 mg/m(2)）的HIPEC方案值得商榷。因此，为解答该临床研究结果无法证实的问题，我们团队正在牵头设计一项符合中国人群HIPEC治疗方案的随机对照研究（HIPEC-06），旨在探索根治性手术联合HIPEC治疗cT(4)期结直肠癌的临床疗效。.
Keywords: Clinical trial; Colorectal neoplasms, advanced; Hyperthermic intraperitoneal chemotherapy; Peritoneal metastases.