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Clinical study on comprehensive treatment of high risk neuroblastoma in children

Clinical study on comprehensive treatment of high risk neuroblastoma in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037505
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Interventions

Sponsors

Children's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1.5 Years to 14 Years

Inclusion criteria

Inclusion criteria: The diagnostic criteria for high-risk neuroblastoma should be one of the following: 1. Patients with stage 3-4 neuroblastoma older than 18 months; 2. There is one or more imaging defined risk factors (IDRFs) and complete remission is not achieved after surgery; 3. Neuroblastoma with N-myc amplification or distant metastasis; 4. Recurrent neuroblastoma: neuroblastoma patients with a new lesion at the primary site or elsewhere, who achieved complete remission for more than four weeks by multidisciplinary treatment; 5. Refractory neuroblastoma: progress in the evaluation of efficacy after 2-4 courses of induction chemotherapy.

Exclusion criteria

Exclusion criteria: (1) There are any contraindications to hematopoietic stem cell transplantation and anti GD2 antibody immunotherapy;(2) There are other serious diseases, such as serious damage of vital organs, respiratory failure, heart failure, liver insufficiency and renal insufficiency in decompensated period; (3) Other clinical researchers are in progress; (4) At the same time, suffering from other severe acute or chronic physiological or mental diseases, or abnormal laboratory examination, may affect the patient's life safety and compliance, affect informed consent, research participation, follow-up or result interpretation.

Design outcomes

Primary

MeasureTime frame
Effective rate of treatment for high-risk neuroblastoma;Overall survival and event-free survival for high-risk neuroblastoma;Recurrence rate;

Secondary

MeasureTime frame
Detection of bone marrow minimal residual lesions and changes in multidrug resistance;Implantation and immune reconstitution;complication;

Countries

China

Contacts

Public ContactJing-bo Shao

Children's Hospital of Shanghai

sjbobo@sina.com+86 18917128086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026