A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer

1. Research background Colorectal cancer (CRC) is one of the most common malignant tumors. Globally, approximately 1 million new cases of colorectal cancer occur each year, and about 500,000 people die from the disease annually. With the improvement of living standards and changes in lifestyle habits, the incidence rate of colorectal cancer is gradually increasing, posing a serious threat to human life. To prevent the occurrence of peritoneal metastasis, based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or raltitrexed provides a feasible approach that can benefit patients with advanced colorectal cancer who undergo first-line treatment for peritoneal metastasis. 2. Research purpose To evaluate the safety and determine the maximum tolerated dose (MTD) of pressurized intraperitoneal aerosol chemotherapy combined with mitomycin or raltitrexed in patients with colorectal cancer and peritoneal metastasis. II. Specific Procedures and Processes 1. Treatment method This trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer. Mitomycin-PIPAC group: Mitomycin (increasing doses: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL was administered via intraperitoneal aerosol chemotherapy under pressure. Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy. PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason). Equipment: Pressure Intraperitoneal Aerosol Chemotherapy (PIPAC) equipment includes an endoscope pulse irrigation device and its supporting instruments, mainly including a display screen, an infusion rack, a liquid sensor, a high-pressure peristaltic pump, and the main structure of the machine; supporting instruments include: 10 mm atomizing nozzle, high-pressure infusion tube, infusion tube puncture head, and 10/12 mm trocar puncture device (2). Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery. systemic chemotherapy regimen The chemotherapy regimen is determined by the clinician based on pathological staging, molecular typing, risk factors, and in accordance with the NCCN and CSCO guidelines. 2. Visit and follow-up Patients came to the hospital for follow-up visits according to the requirements of the research protocol and continued until the end of the study.