RecruitingPhase 1NCT07349043

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

42 participants

Start Date

Jan 1, 2026

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called pressurized intraperitoneal aerosol chemotherapy (PIPAC) — where chemotherapy drugs are delivered as a fine mist directly into the abdomen during a keyhole surgery — for people with colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal metastasis). **You may be eligible if...** - You are 18–75 years old - You have colorectal cancer that has spread to the peritoneum (lining of the abdomen), confirmed by biopsy, with no spread elsewhere - Your expected survival is more than 6 months - Your organs are functioning at acceptable levels - You are able to undergo laparoscopic (keyhole) surgery **You may NOT be eligible if...** - You have a bowel obstruction or blockage - You rely entirely on IV nutrition - You have severe abdominal infection or extensive abdominal scarring - You have portal vein blood clots or severe heart or lung conditions - You are pregnant or breastfeeding - You have a significant psychiatric history - You have been in another clinical trial within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMitomycin-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.

DRUGRaltitrexed-PIPAC

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)

Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China

Hangzhou, Other (Non U.s.), China

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NCT07349043


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