Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 1
Started
2026-01
Last updated
2026-01-16
Condition(s) studied
Peritoneal MetastasisCRC (Colorectal Cancer)
Investigational drug(s) / intervention(s)
Mitomycin-PIPACRaltitrexed-PIPAC
Mitomycin-PIPAC: 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.
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites.
2. No gender limitation, aged 18 to 75 years old;
3. ECOG score ≤2;
4. Subjects without other malignant diseases;
5. Subjects without laparoscopic surgery contraindications;
6. Expected survival period \> 6 months;
7. Able to comprehend and sign the informed consent form;
8. 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 Criteria:
1. Subjects with gastrointestinal obstruction;
2. Subjects who rely entirely on parenteral nutrition;
3. Subjects with decompensated ascites;
4. Subjects with severe abdominal infection (peritonitis);
5. Subjects with extensive abdominal adhesion;
6. Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously;
7. Subjects with portal vein thrombosis;
8. Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.);
9. Previously allergic to chemotherapy drugs;
10. Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs;
11. Pregnant or lactating women;
12. Patients who have participated in or are currently participating in other clinical trials within 3 months;
13. Other situations where the researchers believe that the patient is not suitable to participate in this trial;
14. 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;
Primary outcome measure(s)
Dose-Limiting Toxicity (DLT) — the first 4 weeks 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) — 4 weeks 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) — up to 12 months Monitoring and documenting all adverse events (e.g., nausea, fatigue, pain, hematological effects) following each dose escalation.
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China
Hangzhou
Other (Non U.s.)
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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