Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

• Status: Recruiting
• Trial end date: 2026-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Collaborators: Beijing Cancer Hospital; Beijing Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chongqing University Cancer Hospital; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Fudan University; Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial People's Hospital; Hebei Medical University Fourth Hospital; Jiangmen Central Hospital; Meizhou People's Hospital; Nanfang Hospital of Southern Medical University; Peking University People's Hospital; People's Hospital of Deyang City; People's Hospital of Guangxi; People’s Hospital of Deyang City; Renmin Hospital of Wuhan University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shantou Central Hospital; Shenzhen Second People's Hospital; Sichuan Provincial People's Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; Sun Yat-sen University; The Affiliated Hospital Of Southwest Medical University; The Affiliated Hospital of Xuzhou Medical University; The Affiliated Tumor Hospital of Guangxi Medical University; The First Affiliated Hospital of Nanchang University; The People's Hospital of Leshan; The Second Affiliated Hospital of Chongqing Medical University; The Third People's Hospital of Chengdu; West China Hospital; Wuhan Union Hospital, China; Wuhan University; Zhongshan People's Hospital, Guangdong, China; ZhuHai Hospital

Criteria

Inclusion Criteria:

• Age between 18 and 70 years

• Nonpregnant or breast-feeding women

• ECOG status 0-1

• Colorectal adenocarcinoma or mucinous adenocarcinoma;

• Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - according to AJCC 8th edition) without previous anti-cancer treatment and R0 resection could be achieved

• Laboratory tests within 2 weeks before Randomization：Neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/l, Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×ULN), total bilirubin(TBIL)≤ 1.5 × ULN, serum creatinine ≤ 1.5 ×ULN

• Written informed consent

Exclusion Criteria:

• Rectal cancer below peritoneal reflection

• Concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment)

• Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation

• Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction

• Existence of distance metastasis during surgery (M1) or can not achieve R0 resection

• Contraindiction of mitomycin c(chickenpox or shingles)

• Poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease