[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460602":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":70,"id":75,"slug":46,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":46,"enrollmentInfo":84,"targetDuration":46,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":100,"overallStatus":51,"whyStopped":46,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Nal-IRI (Onivyde) - 30mg\u002Fm²","EXPERIMENTAL","PIPAC with Onivyde (30 mg\u002Fm²) will be administered every 4 to 6 weeks for 3 cycles.",[13],"Drug: PIPAC with Nal-IRI",{"label":15,"type":10,"description":16,"interventionNames":17},"Nal-IRI (Onivyde) - 45mg\u002Fm²","PIPAC with Onivyde (45 mg\u002Fm²) will be administered every 4 to 6 weeks for 3 cycles.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Nal-IRI (Onivyde) - 60mg\u002Fm²","PIPAC with Onivyde (60 mg\u002Fm²) will be administered every 4 to 6 weeks for 3 cycles.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Nal-IRI (Onivyde) - 75mg\u002Fm²","PIPAC with Onivyde (75 mg\u002Fm²) will be administered every 4 to 6 weeks for 3 cycles.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Nal-IRI (Onivyde) - 90mg\u002Fm²","PIPAC with Onivyde (90 mg\u002Fm²) will be administered every 4 to 6 weeks for 3 cycles.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","PIPAC 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\u002Fm². PIPAC will be performed every 4 to 6 weeks for 3 cycles.",[9,15,19,23,27],[37],"Onivyde",[39],{"name":40,"affiliation":5,"role":41},"Wim P Ceelen, MD, PhD, Prof","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+3293326251",null,"wim.ceelen@ugent.be",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"UZ Ghent","RECRUITING","Ghent","East-Flanders","9000","Belgium",{"type":57,"coordinates":58},"Point",[59,60],3.71667,51.05,{"lat":60,"lon":59},[63,64],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":65,"role":44,"phone":66,"phoneExt":46,"email":67},"Wouter Willaert, MD, PhD, Prof","+3293328950","wouter.willaert@ugent.be",{"type":69,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[71,73],{"name":72,"class":6},"Kom Op Tegen Kanker",{"name":74,"class":6},"University Ghent","100460602",false,"NCT05277766","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","PIPAC-NAL-IRI","Inclusion Criteria:\n\n* Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis\n* Estimated life expectancy \\> 6 months; \\> 3 months if primary cancer is pancreatic\n* Age ≥ 18 years\n* Adequate performance status (Karnofsky index \\> 60% and WHO performance status \\\u003C 2)\n* Written informed consent obtained prior any act of the research\n\nExclusion Criteria:\n\n* Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)\n* Pregnancy or breastfeeding during the clinical study\n* 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).\n* Known allergy or intolerance to irinotecan\n* Significant amount of ascites detectable (exceeding 3l in volume)\n* Intestinal or urinary tract obstruction\n* Extensive hepatic and\u002For extra-abdominal metastatic disease\n* Impaired renal function (serum creatinine \\> 1.5 mg\u002Fdl or calculated GFR (CKD-EPI) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Impaired liver function (serum total bilirubin \\> 1.5 mg\u002Fdl, except for known Gilbert's disease)\n* Platelet count \\\u003C 100.000\u002Fµl\n* Hemoglobin \\\u003C 9g\u002Fdl\n* Neutrophil granulocytes \\\u003C 1.500\u002Fml\n* Patients known to use:\n\n  * CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)\n  * inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)","ALL","18 Years",{"count":85,"type":86},45,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","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.",[92,93,94,95,96,97,98,99],"Peritoneal Carcinomatosis","Peritoneal Metastases","Colorectal Cancer","Small Bowel Cancer","Appendix Cancer","Gastric Cancer","Pancreatic Cancer","Bile Duct Cancer",[101,102,103,104,105,106,107,37,108,109,110,111,112,113,114,115,116],"PIPAC","Nal-IRI","Peritoneal carcinomatosis","dose-finding study","pharmacokinetics","pharmacodynamics","safety and efficacy","Primary gastrointestinal cancer","Colorectal cancer","Small bowel cancer","Appendix cancer","Stomach cancer","Pancreatic cancer","Cholangiocarcinoma","dose-escalation study","Peritoneal metastases","2025-06-26",{"date":119,"type":120},"2025-07-01","ACTUAL",{"date":122,"type":120},"2022-11-21",{"date":124,"type":86},"2027-04",{"name":5,"class":6},1]