Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neur… (NCT07318831) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
27 participantsStarted 2025-12-31
Plain-language summary
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.
Who can participate
SexALL
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Inclusion criteria
✓. Patients with histologically diagnosed neuroblastoma, defined according to the International Neuroblastoma Risk Group (INRG) classification system or the Chinese expert consensus/guideline for pediatric neuroblastoma.
✓. Patients with relapsed or refractory neuroblastoma. Relapsed: any patient with recurrent neuroblastoma. Refractory: patients showing an inadequate response (partial response, minor response, or stable disease) to prior therapy, leading to progression.
✓. Prior treatment with epigenetic drugs (e.g., HDAC inhibitors, DNA methylation inhibitors) or GD2 monoclonal antibodies does not affect eligibility for this study.
✓. Bone marrow function: Without bone marrow disease: Platelets ≥75×10⁹/L, Absolute Neutrophil Count (ANC) ≥0.75×10⁹/L, Hemoglobin ≥8 g/dL (transfusion allowed). With bone marrow disease: Platelets ≥50×10⁹/L, ANC ≥0.5×10⁹/L, Hemoglobin ≥8 g/dL (transfusion allowed).
✓. Renal function: No clinically significant proteinuria (morning urine dipstick \<2+). If proteinuria ≥2+ is detected, the protein-to-creatinine (Pr/Cr) ratio must be \<0.5 or 24-hour protein excretion must be \<0.5 g.
Exclusion criteria
✕. Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.
What they're measuring
1
Objective Response Rate（ORR）
Timeframe: From enrollment to the end of treatment at 10 weeks
Trial details
NCT IDNCT07318831
SponsorTianjin Medical University Cancer Institute and Hospital
. Patients with CTCAE v5.0 Grade 2 or higher neurotoxicity.
✕. Major surgical procedure within 14 days prior to the first dose of the study drug.
✕. Severe infection (requiring IV antibiotics, antifungals, or antivirals) within one week prior to treatment, or unexplained fever \>38.5°C during screening or before the first dose.
✕. Congenital or acquired immunodeficiency, or active infectious diseases such as HIV or active hepatitis (with transaminase levels not meeting inclusion criteria; HBV DNA ≥1000 IU/mL; HCV RNA ≥1000 IU/mL). Chronic HBV carriers with HBV DNA \<2000 IU/mL may be enrolled if they receive concurrent antiviral therapy during the trial.
✕. Any concomitant condition that, in the investigator's judgment, seriously jeopardizes patient safety, may confound the study results, or could impede the patient's completion of the study.