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.)
Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites.
No gender limitation, aged 18 to 75 years old;
ECOG score ≤2;
Subjects without other malignant diseases;
Subjects with gastrointestinal obstruction;
Subjects who rely entirely on parenteral nutrition;
Subjects with decompensated ascites;
Subjects with severe abdominal infection (peritonitis);
Single group
Mitomycin-PIPAC
DrugMitomycin-PIPAC group: The patients were treated with mitomycin (increasing dose: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL by pressurized intraperitoneal aerosol chemotherapy.
Raltitrexed-PIPAC
DrugRaltitrexed-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.
Dose-Limiting Toxicity (DLT)
The number and severity of toxicities observed during treatment, as well as their relation to the dose level of MMS or RTX administered via PIPAC.
Maximum Tolerated Dose (MTD)
MTD will be determined based on the highest dose administered where \<33% of patients experience DLTs, or by dose-escalation schemes according to standard practices.
Adverse Events (AEs)
Monitoring and documenting all adverse events (e.g., nausea, fatigue, pain, hematological effects) following each dose escalation.
Maximum Plasma Concentration (Cmax)
To measure the highest plasma concentration of mitomycin (MMS) or raltitrexed (RTX) after PIPAC administration.
Objective Response Rate (ORR)
Measured using imaging techniques and clinical assessment to determine the proportion of patients who achieve complete or partial response.
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death from any cause.
Overall Survival (OS)
Time from treatment initiation to death from any cause.
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