NCT07278674Active, not recruiting
Clinical Study of Eflornithine After Immunotherapy for High-risk Neuroblastoma（CSHEIN）
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
Evaluate the impact of maintenance therapy with eflornithine on event-free survival and overall survival in high-risk neuroblastoma (NB) children after immunotherapy, and assess its safety.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 8 Feb 2025
- Start date
- 8 Apr 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Shanghai Children's Hospital
- Diseases
- Neuroblastoma
- NCT number
- NCT07278674
What you commit to
- Study type: Observational
- Planned participants: 20
- From 8 Apr 2025 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior to enrollment, the disease assessment status was either progressive disease (PD) or relapse (via CT or MRI).
Other
- According to the International Neuroblastoma Risk Group Classification, it has been histologically diagnosed as non high risk NB.
- Positive bone marrow smear.
- Hematological parameters and organ function are not qualified, according to the CI CTC 4.0 adverse reaction grading standard of grade 3 or above.
- The guardian does not agree to participate.
Who the study is looking for
- According to the International Neuroblastoma Risk Group Classification, it has been histologically diagnosed as high-risk NB.
- Under the age of 18.
- The disease assessment status is PR (via CT or MRI) and the bone marrow smear is negative.
- If the residual mass is MIBG negative or MIBG positive and lacks FDG-PET affinity, it is considered evidence that the mass does not represent active disease. Subjects with stable residual tumor mass visible on CT/MRI will be included in the study.
- Qualified hematological parameters and organ function; Refer to the CI CTC 4.0 adverse reaction grading standard of grade 2 and below.
- Eflornithine needs to be activated within 120 days after the completion of previous treatment.
Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Hainan Branch, affiliated with Shanghai Jiao Tong University School of Medicine and Children's Hospital of Shanghai, affiliated with Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Hainan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.