Actively Recruiting
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study
Led by University Hospital, Ghent · Updated on 2025-07-01
45
Participants Needed
1
Research Sites
65 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
Peritoneal metastases often occur in gastrointestinal cancer and are linked to a poor outlook and difficult symptoms like severe fluid buildup and bowel blockage. Researchers are evaluating the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) delivered as a pressurized intraperitoneal aerosol chemotherapy (PIPAC) in a phase I trial. This approach aims to improve drug delivery directly to the affected area, potentially improving outcomes for patients with challenging peritoneal carcinomatosis. The study involves administering aerosolized Nal-IRI directly into the peritoneal cavity using the PIPAC technique. Participants receive escalating doses of Nal-IRI ranging from 30 to 90 mg/m² every 4 to 6 weeks for a total of three treatment cycles. This dose escalation is combined with detailed pharmacokinetic and pharmacodynamic evaluations including drug levels in plasma and tumor tissue, as well as biomarker analysis to monitor safety and response. Participants will undergo regular assessments including plasma and tissue sampling at multiple timepoints to measure drug concentration and effects. Researchers will also evaluate surgical complications, quality of life through various questionnaires, pain levels, and overall treatment response up to 12 months after treatment. The primary outcome is to determine the maximal tolerated dose of Nal-IRI within 14 weeks of starting treatment. This comprehensive monitoring helps understand both the safety and potential impact of the treatment over time.
CONDITIONS
Brief Title
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
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 greater than 60% and WHO performance status less than 2)
- Written informed consent obtained prior to any research activity
You will not qualify if you...
- Receiving systemic intravenous treatment with irinotecan (alone or in combination regimens such as FOLFIRI, CAPIRI, or FOLFOXIRI)
- Pregnant or breastfeeding during the study
- Childbearing age without effective contraception during the study and until 30 days after exposure for females or 120 days for males
- Known allergy or intolerance to irinotecan
- Significant ascites exceeding 3 liters in volume
- Intestinal or urinary tract obstruction
- Extensive liver or extra-abdominal metastatic disease
- Impaired kidney function (serum creatinine over 1.5 mg/dl or estimated GFR under 60 mL/min/1.73 m²)
- Impaired liver function (serum total bilirubin over 1.5 mg/dl, except Gilbert's disease)
- Low platelet count (below 100,000/µl)
- Low hemoglobin (below 9 g/dl)
- Low neutrophil count (below 1,500/ml)
- Use of drugs that induce or inhibit CYP3A4 or UGT1A1 enzymes as listed in the criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 18 weeks
Participants receive intraperitoneal aerosolized nanoliposomal irinotecan (Nal-IRI) using the PIPAC technique. The treatment involves 3 cycles with doses escalating from 30 to 90 mg/m² administered every 4 to 6 weeks.
3 treatment visits every 4 to 6 weeks
Duration - Up to 12 months
Participants are monitored for safety, treatment response, and quality of life for up to 12 months after the last treatment cycle.
Visits at 3 months, 6 months, and 12 months after last treatment
Trial Site Locations
Total: 1 location
1
UZ Ghent
Ghent, East-Flanders, Belgium, 9000
Actively Recruiting
Research Team
W
Wim P Ceelen, MD, PhD, Prof
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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