Status:
RECRUITING
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Kom Op Tegen Kanker
University Ghent
Conditions:
Peritoneal Carcinomatosis
Peritoneal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (PI...
Detailed Description
Peritoneal metastases (PM) are a common manifestation of gastrointestinal cancer. The prognosis of patients with PM is particularly poor, and response to systemic chemotherapy is worse compared to par...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
- Pregnancy or breastfeeding during the clinical study
- 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).
- Known allergy or intolerance to irinotecan
- Significant amount of ascites detectable (exceeding 3l in volume)
- Intestinal or urinary tract obstruction
- Extensive hepatic and/or extra-abdominal metastatic disease
- 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
- 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)
Key Trial Info
Start Date :
November 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05277766
Start Date
November 21 2022
End Date
April 1 2027
Last Update
July 1 2025
Active Locations (1)
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1
UZ Ghent
Ghent, East-Flanders, Belgium, 9000