Neuroblastoma (NB)Phase 2NCT07318831
Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
A Phase 2 study testing Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide in people with Neuroblastoma (NB) and Neuroblastoma in Children, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Neuroblastoma (NB), Neuroblastoma in Children
- What is being tested?
- Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 0-18 years at enrolment.
- Histologically diagnosed neuroblastoma defined as high-risk according to the International Neuroblastoma Risk Group classification or Chinese consensus/guideline risk classification.
- 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.
- Prior exposure to histone deacetylase inhibitors, DNA methylation inhibitors or GD2 monoclonal antibodies does not preclude eligibility.
- Presence of evaluable disease.
- Performance status of Lansky score >=50%, Karnofsky score >=50% or ECOG performance status <=3.
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- Life expectancy >=12 weeks.
- 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.
- 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.
- 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.
- 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.
- Cardiac shortening fraction >=29% on echocardiography.
- 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.
- Oxygen saturation >94% without supplemental oxygen. Ability to comply with the visit schedule and other protocol requirements.
Who cannot join
- Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yan Jin, PhD, 0086-23340123, jinyan0713@tmu.edu.cn
About this study
Official title: A Phase II Trial of Chidamide Combined With Dinutuximab Beta, Irinotecan, and Temozolomide for Refractory or Relapsed Neuroblastoma in Children
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.
- Conditions
- Neuroblastoma (NB), Neuroblastoma in Children
- Being tested
- Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide Combined with Dinutuximab Beta, Irinotecan, and TemozolomideDrug
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 group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Not described Receives: Drug: Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
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.
Measured: 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).
Secondary outcomes (5)
Progression-Free Survival(PFS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
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.
Measured: Safety will be assessed from the first dose through 28 days after the last dose or initiation of new anticancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start6 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroblastoma (NB)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318831
- Sponsor's protocol ID
- E20251314
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Chidamide Combined With Dinutuximab Beta, Irinotecan, and Temozolomide for Refractory or Relapsed Neuroblastoma in Children
- ClinicalTrials.gov ID
- NCT07318831
- Acronym / sponsor ID
- E20251314
- Conditions
- Neuroblastoma (NB), Neuroblastoma in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide | Experimental | Drug: Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Age 0-18 years at enrolment.
- Histologically diagnosed neuroblastoma defined as high-risk according to the International Neuroblastoma Risk Group classification or Chinese consensus/guideline risk classification.
- 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.
- Prior exposure to histone deacetylase inhibitors, DNA methylation inhibitors or GD2 monoclonal antibodies does not preclude eligibility.
- Presence of evaluable disease.
Key exclusion criteria (6 listed)
- Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide Combined with Dinutuximab Beta, Irinotecan, and TemozolomideChidamide (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. | Drug | Chidamide |
Primary outcome
Objective Response Rate（ORR）
Time frame: 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.
5 secondary outcomes
Progression-Free Survival(PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Safety will be assessed from the first dose through 28 days after the last dose or initiation of new anticancer therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide in people with Neuroblastoma (NB) and Neuroblastoma in Children, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Jin (+8613212163398, myyaner520@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.