A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University
42 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
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.)
Eligibility
Inclusion Criteria8
- 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 without laparoscopic surgery contraindications;
- Expected survival period \> 6 months;
- Able to comprehend and sign the informed consent form;
- The function of important organs should meet the following requirements; The absolute neutrophil count (ANC) is ≥1.5×10\^9/L; Platelets ≥ 100×10\^9/L; Hemoglobin ≥8.0g/dl (Note: It is acceptable to achieve hemoglobin ≥8.0g/dl through blood transfusion or other interventions); serum albumin ≥2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST ≤1.5 times ULN; if there is liver metastasis, ALT and AST ≤5 times ULN; Creatinine clearance rate ≥50mL/min
Exclusion Criteria14
- Subjects with gastrointestinal obstruction;
- Subjects who rely entirely on parenteral nutrition;
- Subjects with decompensated ascites;
- Subjects with severe abdominal infection (peritonitis);
- Subjects with extensive abdominal adhesion;
- Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously;
- Subjects with portal vein thrombosis;
- Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.);
- Previously allergic to chemotherapy drugs;
- Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs;
- Pregnant or lactating women;
- Patients who have participated in or are currently participating in other clinical trials within 3 months;
- Other situations where the researchers believe that the patient is not suitable to participate in this trial;
- Previously had a history of neurological or psychiatric disorders that would affect study informed consent or follow-up evaluation, such as severe depression or dementia;
Interventions
Mitomycin-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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07349043