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Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET

StatusEnrolling by Invitation
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 15, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date: Jul 18, 2022 to Aug 14, 2025v3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025
    • Start date changed from estimate of Jul 1, 2022 to Jul 18, 2022
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.
Trial Details
NCT Number NCT05385861
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions
(from sponsor)		 GEP-NET
Related terms Gastro-enteropancreatic neuroendocrine tumor
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov