Trial · NCT07318831
Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
NCT07318831, Phase 2, Recruiting, Tianjin Medical University Cancer Institute and Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children. Trials, record NCT07318831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07318831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
- NCT number
- NCT07318831
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 27 participants, estimated
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Conditions
- Neuroblastoma (NB), Neuroblastoma in Children
- Interventions
- Chidamide Combined with Dinutuximab Beta, Irinotecan, and Temozolomide
- First posted
- 2026-01-06
- Last updated
- 2026-10-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate（ORR） | 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. |
| Secondary | Progression-Free Survival(PFS) | 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. | |
| Secondary | Event-Free Survival(EFS) | 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. | |
| Secondary | Duration of Response(DOR) | 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. | |
| Secondary | Overall Survival (OS) | From the date of the first dose of study treatment until the date of death from any cause, assessed up to 5 years. | |
| Secondary | Safety assession | 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. |
| Other | Exploratory endpoints | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07318831
GET https://conductscience.org/api/trials/v1/NCT07318831/registered