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
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.)
CONDITIONS
Official 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...
- Diagnosed with peritoneal metastatic adenocarcinoma from colorectal cancer confirmed by pathology
- No metastases outside the peritoneum
- Any gender, aged 18 to 75 years
- ECOG performance status of 0 to 2
- No other malignant diseases present
- No contraindications to laparoscopic surgery
- Expected survival longer than 6 months
- Able to understand and sign informed consent
- Adequate organ function including neutrophils, platelets, hemoglobin (≥8.0 g/dL), serum albumin (≥2.8 g/dL), bilirubin, liver enzymes, and kidney function
You will not qualify if you...
- Presence of gastrointestinal obstruction
- Dependence on parenteral nutrition
- Decompensated ascites
- Severe abdominal infection such as peritonitis
- Extensive abdominal adhesions
- Underwent simultaneous tumor reduction and gastrointestinal reconstruction surgery
- Portal vein thrombosis
- Severe or uncontrolled heart, lung, liver, kidney, blood, or infectious diseases
- Allergy to chemotherapy drugs
- Severe mental illness or drug abuse
- Pregnant or breastfeeding women
- Participation in other clinical trials within the past 3 months
- Conditions judged 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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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
CONTACT
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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