Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05277766

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

Led by University Hospital, Ghent · Updated on 2025-07-01

45

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

K

Kom Op Tegen Kanker

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis
  • Estimated life expectancy greater than 6 months; greater than 3 months if primary cancer is pancreatic
  • Age 18 years or older
  • Adequate performance status (Karnofsky index above 60% and WHO performance status below 2)
  • Written informed consent obtained before any research procedures
Not Eligible

You will not qualify if you...

  • Receiving intravenous irinotecan treatment (alone or in combination regimens such as FOLFIRI, CAPIRI, or FOLFOXIRI)
  • Pregnant or breastfeeding during the study
  • Childbearing age patients unable or unwilling to use effective contraception during the study and for 30 days (female) or 120 days (male) after treatment
  • Known allergy or intolerance to irinotecan
  • Significant ascites exceeding 3 liters in volume
  • Intestinal or urinary tract obstruction
  • Extensive liver and/or extra-abdominal metastatic disease
  • Impaired kidney function (serum creatinine above 1.5 mg/dl or GFR below 60 mL/min/1.73 m²)
  • Impaired liver function (serum total bilirubin above 1.5 mg/dl, except Gilbert's disease)
  • Low platelet count (below 100,000/µl)
  • Low hemoglobin (below 9 g/dl)
  • Low neutrophil granulocyte count (below 1,500/ml)
  • Use of certain medications affecting CYP3A4 or UGT1A1 enzymes, including specific inducers and inhibitors listed in the criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Ghent

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

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Research Team

W

Wim P Ceelen, MD, PhD, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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