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Clinical research on efficacy and safety of combined chemotherapy with arsenic trioxide in stage 4/M neuroblastoma: a prospective, single-arm, open-label, multi-center study

Clinical research on efficacy and safety of combined chemotherapy with arsenic trioxide in stage 4 neuroblastoma: a prospective, single-arm, open-label, multi-center study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014748
Enrollment
Unknown
Registered
2018-02-02
Start date
2019-01-01
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

Stage 4/M neuroblastoma

Interventions

Experimental group:Combined induction chemotherapy with arsenic trioxide

Sponsors

Sun Yat-Sen Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: 1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System(INSS) or the International Neuroblastoma Risk Group (INRG) staging system; 2. Patients not more than 14 years old; 3. There are measurable lesions; 4. Guardians agreed and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiation; 2. Patients with one or more critical organs failure such as heart, brain, kidney failure.

Design outcomes

Primary

MeasureTime frame
Objective response rate after ATO-combined induction chemotherapy;

Secondary

MeasureTime frame
Progression-free survival;Incidence of adverse events;3-year overall survival;

Countries

China

Contacts

Public ContactYang Li

Sun Yat-Sen Memorial Hospital

drliyang@126.com+86 020-81332045

Outcome results

None listed

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