Phase 1 Study of Pressurized Intraperitoneal Aerosol Chemotherapy with Mitomycin or Raltitrexed for Treating Colorectal Cancer with Peritoneal Metastasis

What this Trial Is About

This research aims to evaluate the safety and determine the maximum tolerated dose MTD of pressurized intraperitoneal aerosol chemotherapy PIPAC combined with mitomycin or raltitrexed for patients with colorectal cancer that has spread to the peritoneum. Colorectal cancer is a common and serious disease with limited effective treatment options for those with peritoneal metastasis. This Phase I trial seeks new treatment strategies to improve survival and prognosis while ensuring patients also receive standard first-line care. The study compares two groups receiving PIPAC one treated with mitomycin at increasing doses combined with saline, and the other treated with raltitrexed at escalating doses combined with saline. Treatments are delivered via pressurized aerosol chemotherapy inside the abdomen once every 4 to 6 weeks for three sessions. Surgery follows tumor reduction principles, and systemic chemotherapy is given based on clinical guidelines and patient specifics. The study uses specialized PIPAC equipment and carefully monitors dosing and treatment safety. Participants will attend scheduled visits and follow-ups throughout the study, which continues until its end. Researchers will assess dose-limiting toxicities within the first 4 weeks, establish the maximum tolerated dose, and monitor adverse events for up to 12 months. Additional measures include blood drug levels, tumor response, progression-free survival, and overall survival. Safety and treatment effects are carefully tracked to inform future care options for this patient group.

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