NCT05277766Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 18 Feb 2022
- Start date
- 21 Nov 2022
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT05277766
- EU CT number
- 2023-509135-17-00
- EudraCT number
- 2021-006266-20
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 45
- From 21 Nov 2022 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
- Patients known to use:
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)
- inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)
Other illness
- Known allergy or intolerance to irinotecan
- Extensive hepatic and/or extra-abdominal metastatic disease
Lab values
- Impaired renal function (serum creatinine \> 1.5 mg/dl or calculated GFR (CKD-EPI) \< 60 mL/min/1.73 m²
- Impaired liver function (serum total bilirubin \> 1.5 mg/dl, except for known Gilbert's disease)
- Platelet count \< 100.000/µl
- Hemoglobin \< 9g/dl
- Neutrophil granulocytes \< 1.500/ml
Age
- Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).
Other
- Pregnancy or breastfeeding during the clinical study
- Significant amount of ascites detectable (exceeding 3l in volume)
- Intestinal or urinary tract obstruction
Who the study is looking for
- 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 \> 6 months; \> 3 months if primary cancer is pancreatic
- Age ≥ 18 years
- Adequate performance status (Karnofsky index \> 60% and WHO performance status \< 2)
- Written informed consent obtained prior any act of the research
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.