Actively Recruiting
A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-16
42
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and determine the maximum tolerated dose (MTD) of pressurized intraperitoneal aerosol chemotherapy (PIPAC) combined with mitomycin or raltitrexed for patients with colorectal cancer that has spread to the peritoneum. Colorectal cancer is a common and serious disease with limited effective treatment options for those with peritoneal metastasis. This Phase I trial seeks new treatment strategies to improve survival and prognosis while ensuring patients also receive standard first-line care. The study compares two groups receiving PIPAC: one treated with mitomycin at increasing doses combined with saline, and the other treated with raltitrexed at escalating doses combined with saline. Treatments are delivered via pressurized aerosol chemotherapy inside the abdomen once every 4 to 6 weeks for three sessions. Surgery follows tumor reduction principles, and systemic chemotherapy is given based on clinical guidelines and patient specifics. The study uses specialized PIPAC equipment and carefully monitors dosing and treatment safety. Participants will attend scheduled visits and follow-ups throughout the study, which continues until its end. Researchers will assess dose-limiting toxicities within the first 4 weeks, establish the maximum tolerated dose, and monitor adverse events for up to 12 months. Additional measures include blood drug levels, tumor response, progression-free survival, and overall survival. Safety and treatment effects are carefully tracked to inform future care options for this patient group.
CONDITIONS
Brief Title
A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with peritoneal metastatic adenocarcinoma of colorectal origin confirmed by histopathology, without metastasis to other sites
- Any gender, aged 18 to 75 years
- ECOG performance status score of 2 or less
- No other malignant diseases present
- No contraindications for laparoscopic surgery
- Expected survival period longer than 6 months
- Able to understand and sign informed consent
- Adequate organ function including ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥8.0 g/dl (may be achieved through intervention), serum albumin ≥2.8 g/dL, bilirubin ≤1.5 times ULN, ALT and AST ≤1.5 times ULN (or ≤5 times ULN if liver metastasis), creatinine clearance rate ≥50 mL/min
You will not qualify if you...
- Presence of gastrointestinal obstruction
- Reliance entirely on parenteral nutrition
- Decompensated ascites
- Severe abdominal infection such as peritonitis
- Extensive abdominal adhesions
- Previous combined tumor reduction surgery and gastrointestinal resection/reconstruction
- Portal vein thrombosis
- Severe or uncontrolled medical conditions including heart, lung, liver, kidney diseases or infections
- Allergy to chemotherapy drugs
- Severe mental illness or history of drug abuse
- Pregnant or breastfeeding women
- Participation in another clinical trial within the last 3 months
- Other conditions deemed unsuitable by researchers
- History of neurological or psychiatric disorders affecting consent or follow-up, such as severe depression or dementia
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 to 18 weeks (3 courses, 4-6 weeks each)
Participants receive pressurized intraperitoneal aerosol chemotherapy with either mitomycin or raltitrexed. The treatment is given once every 4 to 6 weeks for up to 3 courses. Surgical tumor reduction may also be performed following specific surgical plans. Systemic chemotherapy is provided as determined by the treating clinicians.
3 treatment visits (in-person) spaced 4 to 6 weeks apart
Duration - Up to 12 months
Participants are monitored for safety, treatment response, and survival outcomes for up to 12 months after treatment completion.
Follow-up visits scheduled according to the study protocol
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China
Hangzhou, Other (Non U.s.), China, 310000
Actively Recruiting
Research Team
L
Lifeng Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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