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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07318831
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuroblastoma (NB)
  • Neuroblastoma in Children

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide — DRUG
    Chidamide (C): 5 mg/10 kg (maximum single dose: 30 mg), administered twice per week. The medication follows a schedule of two weeks on treatment followed by one week off. Specifically, it is taken orally on Days 0, 3, 7, and 10 of each three-week cycle. Chidamide is initiated one day before the start of chemotherapy.

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chidamide

Primary Outcome Measure

Objective Response Rate（ORR） [ Time Frame: From enrollment to the end of treatment at 10 weeks ]

Central Contacts