A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Summary
For colorectal cancer with peritoneal metastasis, the current first-line standard treatment offers very limited benefits and short survival. Therefore, it is necessary to seek new treatment strategies to improve the prognosis and survival of such patients. Based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or RTX provides a feasible solution that can benefit patients with advanced colorectal cancer and peritoneal metastasis undergoing first-line treatment. This study aims to evaluate the effectiveness of PIPAC combined with MMC or RTX as first-line treatment for patients with colorectal cancer and peritoneal metastasis, while ensuring that patients receive standard first-line treatment. (The main purpose of the proposed Phase I trial is to determine the MTD of PIPAC combined with MMC or RTX and evaluate the safety of combining it with systemic chemotherapy for patients with colorectal cancer and peritoneal metastasis.)
Timeline
- Start
- 2026-01
- Primary completion
- 2027-10
- Completion
- 2028-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 5 mg/m2 | Other |
| Subject | Mitomycin C | Other / unclassified | 10 mg/m2 | Other |
| Subject | Mitomycin C | Other / unclassified | 15 mg/m2 | Other |
| Subject | Mitomycin C | Other / unclassified | 20 mg/m2 | Other |
| Subject | Raltitrexed | Small molecule | 1 mg/m2 | Other |
| Subject | Raltitrexed | Small molecule | 1.5 mg/m2 | Other |
| Subject | Raltitrexed | Small molecule | 2 mg/m2 | Other |
| Subject | Raltitrexed | Small molecule | 2.5 mg/m2 | Other |
| Subject | Raltitrexed | Small molecule | 3 mg/m2 | Other |