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

Study acronym: PIPAC-NAL-IRI
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 13, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 2026 to Aug 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2027 to Aug 1, 2027
    • Site details revised
    v9
  2. Primary completion date: Aug 2025 to Jan 2026
    • Study completion date: Jan 1, 2027 to Apr 2027
    v8
  3. Study Identification, Study Status, Referencesv7
  4. Re-verified, no change to tracked fieldsv6
  5. Study completion date: Feb 2027 to Jan 1, 2027
    • Start date: Nov 16, 2022 to Nov 21, 2022
    • Secondary endpoints: details revised at 7 of 16 entries
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 21, 2022 to Nov 16, 2022
    • Site details revised
    v4
  2. Enrollment target: 30 to 45
    • Start date: Sep 2022 to Nov 21, 2022
    v3
  3. Start date: Apr 2022 to Sep 2022
    • Study completion date: Aug 2026 to Feb 2027
    • Secondary endpoints: details revised at 6 of 16 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University Hospital, Ghent
165 trials monitored
See 6 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Pancreatic Cancer
1,739 trials monitored
See 106 trials at risk
Gastric Cancer
1,278 trials monitored
See 63 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT05277766
Lead Sponsor University Hospital, Ghent
Collaborators: Kom Op Tegen Kanker, University Ghent
Conditions
(from sponsor)		 Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Small Bowel Cancer, Appendix Cancer, Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer
Related terms Appendiceal Neoplasms, Bile Duct Neoplasms, Cholangiocarcinoma, Colorectal Neoplasms, Pancreatic Neoplasms, Peritoneal Neoplasms, Stomach Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov