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Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria shortened, about 20 words
    • Secondary endpoints: 4 to 5
    • Site details revised
  2. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 31, 2025 to Jan 6, 2026
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II clinical trial investigating the effectiveness and safety of a four-drug combination-Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide-for children with relapsed or refractory neuroblastoma. The primary goal is to evaluate how well this regimen works to control the cancer, while the secondary goal is to closely monitor its safety and side effects in these young patients.
Trial Details
NCT Number NCT07318831
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions
(from sponsor)		 Neuroblastoma (NB), Neuroblastoma in Children
Related terms Neuroblastoma
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov