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

Launched by UNIVERSITY HOSPITAL, GHENT · Mar 11, 2022

Keywords

ClinConnect Summary

The PIPAC NAL-IRI study is a clinical trial looking to find the highest safe dose of a treatment called nanoliposomal irinotecan (Nal-IRI) for patients with advanced cancer that has spread within the abdominal cavity, known as peritoneal carcinomatosis. This condition can occur with various types of gastrointestinal cancers, including colorectal, gastric, and pancreatic cancers. The trial involves administering this treatment through a special method called pressurized intraperitoneal aerosol chemotherapy (PIPAC).

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of specific cancers with extensive disease that cannot be surgically removed. They should also have an estimated life expectancy of more than six months, or three months if their primary cancer is pancreatic. Participants will need to provide informed consent and meet certain health criteria before joining. Throughout the trial, participants will be closely monitored to assess how well they tolerate the treatment and its effects on their condition. It's important to note that some patients may not be eligible due to other health issues or ongoing treatments.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)