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Efficacy of HIPEC for colorectal cancer patients at high risk of peritoneal carcinomatosis

A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

Phase 3 Interventional Affiliated Cancer Hospital & Institute of Guangzhou Medical University · NCT04370925

This study is testing if a special type of chemotherapy given during surgery can help colorectal cancer patients who are at high risk of cancer spreading in their abdomen live longer and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment688 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University Academic / other
Drugs / interventionschemotherapy
Locations37 sites (Beijing, Beijing and 36 other locations)
Trial IDNCT04370925 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with radical colectomy in patients with colorectal cancer who are at high risk for developing peritoneal carcinomatosis. Participants will be randomly assigned to receive either HIPEC with Mitomycin C or standard systemic chemotherapy following their surgery. The primary goal is to assess peritoneal recurrence-free survival, while secondary outcomes include overall survival, disease-free survival, and quality of life metrics. The study aims to provide insights into the potential benefits of prophylactic HIPEC in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with intraoperatively confirmed cT4N0-2M0 colorectal adenocarcinoma who are eligible for radical colectomy.

Not a fit: Patients with rectal cancer below the peritoneal reflection or those with other concurrent cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of peritoneal recurrence in colorectal cancer patients.

How similar studies have performed: Previous studies have shown promise with HIPEC in treating peritoneal carcinomatosis, but its use as a prophylactic measure in colorectal cancer remains less established.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Beijing, Beijing and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerColorectal cancerColectomyHyperthermic intraperitoneal chemotherapyPeritoneal carcinomatosis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.