OncoMatch/Clinical Trials/NCT05277766
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
Is NCT05277766 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PIPAC with Nal-IRI for peritoneal carcinomatosis.
Treatment: PIPAC with Nal-IRI — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Cholangiocarcinoma
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: irinotecan-containing regimen (irinotecan, FOLFIRI, CAPIRI, FOLFOXIRI)
Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
Lab requirements
Blood counts
platelet count ≥ 100,000/µl; hemoglobin ≥ 9g/dl; neutrophil granulocytes ≥ 1,500/ml
Kidney function
serum creatinine ≤ 1.5 mg/dl or calculated GFR (CKD-EPI) ≥ 60 mL/min/1.73 m²
Liver function
serum total bilirubin ≤ 1.5 mg/dl (except for known Gilbert's 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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