RecruitingPhase 1NCT05277766

Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer

Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study


Sponsor

University Hospital, Ghent

Enrollment

45 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new way to deliver irinotecan chemotherapy — as a mist sprayed directly inside the abdomen (intraperitoneal aerosol) — for people with extensive peritoneal carcinomatosis (cancer spread throughout the abdominal lining) from GI cancers such as pancreatic, colon, stomach, gallbladder, or appendix cancer. **You may be eligible if...** - You are 18 or older with biopsy-proven gastrointestinal cancer with extensive spread inside the abdomen - Your cancer cannot be surgically removed - Your life expectancy is more than 6 months (or more than 3 months for pancreatic cancer) - You have an adequate performance status **You may NOT be eligible if...** - You are currently receiving IV irinotecan chemotherapy - You are pregnant or breastfeeding - You are of childbearing age and unable to use effective contraception - You have a known allergy to irinotecan - You have significant amounts of ascites (fluid in the abdomen) 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

DRUGPIPAC with Nal-IRI

Nanoliposomal irinotecan (Nal-IRI, Onivyde) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 30 to 90 mg/m². PIPAC will be performed every 4 to 6 weeks for 3 cycles.


Locations(1)

UZ Ghent

Ghent, East-Flanders, Belgium

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NCT05277766


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