Clinical trial · Interventional
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
NCT05277766CI-TRIAL-00117765PIPAC-NAL-IRIactive not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendix Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Metastases | — | UNRESOLVED | — |
| Small Bowel Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC with Nal-IRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Nal-IRI (Onivyde) - 30mg/m²
- description
- PIPAC with Onivyde (30 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
- interventionNames
- Drug: PIPAC with Nal-IRI
- type
- EXPERIMENTAL
- label
- Nal-IRI (Onivyde) - 45mg/m²
- description
- PIPAC with Onivyde (45 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
- interventionNames
- Drug: PIPAC with Nal-IRI
- type
- EXPERIMENTAL
- label
- Nal-IRI (Onivyde) - 60mg/m²
- description
- PIPAC with Onivyde (60 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.