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小児における難治性／再発性神経芽腫に対するチダミド-ジヌツキシマブ ベータ-イリノテカン-テモゾロミドの第II相試験

2026年9月27日 更新者：Tianjin Medical University Cancer Institute and Hospital

小児の難治性または再発性神経芽腫に対するチダミドとジヌツキシマブベータ、イリノテカン、およびテモゾロミド併用の第II相試験

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

27

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300060
        • 募集
        • Tianjin Medical University Cancer Institute & Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1秒～18年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age 0-18 years at enrolment.
  2. Histologically diagnosed neuroblastoma defined as high-risk according to the International Neuroblastoma Risk Group classification or Chinese consensus/guideline risk classification.
  3. Relapsed or refractory neuroblastoma. Relapse is defined as any recurrence of neuroblastoma. Refractory disease is defined as inadequate response to prior therapy, including partial response, minor response or stable disease, followed by progression.
  4. Prior exposure to histone deacetylase inhibitors, DNA methylation inhibitors or GD2 monoclonal antibodies does not preclude eligibility.
  5. Presence of evaluable disease.
  6. Performance status of Lansky score >=50%, Karnofsky score >=50% or ECOG performance status <=3.
  7. Life expectancy >=12 weeks.
  8. Adequate bone marrow function: for patients without bone marrow disease, platelet count >=75 x 10^9/L, absolute neutrophil count >=0.75 x 10^9/L and haemoglobin >=8 g/dL with transfusion permitted; for patients with bone marrow disease, platelet count >=50 x 10^9/L, absolute neutrophil count >=0.5 x 10^9/L and haemoglobin >=8 g/dL with transfusion permitted.
  9. Renal function without clinically significant proteinuria. If urine dipstick protein is >=2+, protein:creatinine ratio must be <0.5 or 24-hour protein excretion must be <0.5 g.
  10. Serum creatinine <=1.5 x upper limit of normal or calculated glomerular filtration rate >=60 mL/min/1.73 m2 if serum creatinine is higher.
  11. Adequate liver function: AST or ALT <=2.5 x upper limit of normal and total bilirubin <=1.5 x upper limit of normal; in the presence of hepatic metastases, AST or ALT <=5 x upper limit of normal and total bilirubin <=2.5 x upper limit of normal.
  12. Cardiac shortening fraction >=29% on echocardiography.
  13. Coagulation function with INR <=1.5 and APTT <=1.5 x upper limit of normal for age if not receiving anticoagulation; anticoagulation is permitted if INR or APTT is within the therapeutic range and the dose has been stable for at least 2 weeks before registration.
  14. Oxygen saturation >94% without supplemental oxygen. Ability to comply with the visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.
  2. Patients with CTCAE v5.0 Grade 2 or higher neurotoxicity.
  3. Major surgical procedure within 14 days prior to the first dose of the study drug.
  4. 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.
  5. 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.
  6. 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：チダミデ
薬：Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate（ORR）
時間枠：Baseline and after Cycles 3, 5 or 6, 7 or 8, and 10 (each cycle is 21 days; up to 30 weeks), or earlier if clinically indicated, during treatment and follow-up (up to 5 years).

The primary endpoint is defined identically in both sources as the confirmed best overall response of CR or PR per the revised INRC during up to 10 cycles.
Baseline and after Cycles 3, 5 or 6, 7 or 8, and 10 (each cycle is 21 days; up to 30 weeks), or earlier if clinically indicated, during treatment and follow-up (up to 5 years).

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-Free Survival(PFS)
時間枠：From the date of the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to 5 years.
From the date of the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to 5 years.
Event-Free Survival(EFS)
時間枠：From the date of the first dose of study treatment until the first documented disease progression or relapse per the revised INRC, development of a secondary malignancy, or death from any cause, whichever occurs first, assessed up to 5 years.
From the date of the first dose of study treatment until the first documented disease progression or relapse per the revised INRC, development of a secondary malignancy, or death from any cause, whichever occurs first, assessed up to 5 years.
Duration of Response(DOR)
時間枠：From the date of first documented complete or partial response per the revised INRC until the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to 5 years.
From the date of first documented complete or partial response per the revised INRC until the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to 5 years.
Overall Survival (OS)
時間枠：From the date of the first dose of study treatment until the date of death from any cause, assessed up to 5 years.
From the date of the first dose of study treatment until the date of death from any cause, assessed up to 5 years.
Safety assession
時間枠：Safety will be assessed from the first dose through 28 days after the last dose or initiation of new anticancer therapy

Safety will be assessed from the first dose through 28 days after the last dose or initiation of new anticancer therapy, whichever occurs first, using adverse events, serious adverse events, grade, seriousness, relatedness, dose modifications and treatment discontinuation.
Safety will be assessed from the first dose through 28 days after the last dose or initiation of new anticancer therapy

その他の成果指標

結果測定
メジャーの説明
時間枠
Exploratory endpoints
時間枠：Baseline (after enrolment and before the first dose), during treatment (up to 2 years), and at relapse or disease progression.

Exploratory endpoints include changes in immune cells and cytokines; transcriptomic assessment of cell state and its association with efficacy and survival; immunohistochemistry, immunocytochemistry or flow cytometry assessment of GD2 expression; assessment of ST8SIA1 and YAP1 expression; exploration of NSE, VMA, LDH and ferritin as biomarkers of efficacy and survival; and monitoring of plasma ctDNA ST8SIA1 methylation before treatment, after treatment and at relapse or progression.
Baseline (after enrolment and before the first dose), during treatment (up to 2 years), and at relapse or disease progression.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tianjin Medical University Cancer Institute and Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月6日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2025年12月14日

QC基準を満たした最初の提出物

2026年1月4日

最初の投稿 (実際)

2026年1月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月27日

最終確認日

2026年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • E20251314

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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