Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with mitomycin or raltitrexed for colorectal cancer spread to the peritoneum

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

This Phase I study tests PIPAC with mitomycin or raltitrexed alongside standard systemic chemotherapy to see if it is safe and to find the best dose for people whose colorectal cancer has spread to the peritoneum.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Other (Non U.s.))
• Trial ID: NCT07349043 on ClinicalTrials.gov

What this trial studies

This is a prospective Phase I, dose-escalation trial testing pressurized intraperitoneal aerosol chemotherapy (PIPAC) given with either mitomycin or raltitrexed in patients with colorectal adenocarcinoma limited to peritoneal metastasis. Patients receive repeated laparoscopic PIPAC procedures with escalating drug doses (mitomycin 5–20 mg/m2; raltitrexed 1–3 mg/m2) combined with standard systemic first-line chemotherapy. The primary goal is to determine the maximum tolerated dose (MTD) and to characterize safety and tolerability when PIPAC is combined with systemic treatment. Secondary observations include feasibility, procedural complications, and early signals of tumor response or symptom benefit.

Who should consider this trial

Good fit: Adults 18–75 years old with histologically confirmed colorectal adenocarcinoma confined to peritoneal metastasis, ECOG ≤2, adequate organ function, no other active malignancies, and no contraindication to laparoscopy are ideal candidates.

Not a fit: Patients with distant (non‑peritoneal) metastases, gastrointestinal obstruction, inability to undergo laparoscopy, poor performance status, or significant organ dysfunction are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding PIPAC with mitomycin or raltitrexed could improve local control of peritoneal disease and potentially extend survival or reduce abdominal symptoms compared with systemic therapy alone.

How similar studies have performed: Early-phase PIPAC studies in various peritoneal cancers have shown acceptable safety and some tumor responses, but using mitomycin or raltitrexed as first-line combination therapy with systemic chemotherapy is relatively novel and not yet proven.

Eligibility criteria

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;

Where this trial is running

Hangzhou, Other (Non U.s.)

• Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China — Hangzhou, Other (Non U.s.), China (Recruiting)

Study contacts

• Study coordinator: Lifeng Sun

Conditions Peritoneal Metastasis; CRC; peritoneal metastasis; PIPAC