2026-09-09
minor
Study Status, Eligibility v6
Eligibility criteria+462 characters
Inclusion Criteria:
Age ≥ 2 years old, regardless of gender;
ECOG performance status (PS) score: 0～1;
The expected survival time is more than 12 weeks;
Children with neuroblastoma confirmed by histopathology;
Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain com [...] Age ≥2 years (for patients enrolled in Phase 1, age <18 years); no gender restriction.
Karnofsky Performance Status (KPS) score ≥50 for patients aged ≥16 years, or Lansky Performance Status (LPS) score ≥50 for patients aged <16 years (see Appendix 1).
Estimated life expectancy of [...] [...]
2026-09-01
notable
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Trial completed
Eligibility criteria-10 characters
Inclusion Criteria:
5yearsAge ≤≥ age ≤182 years old, regardless of gender;;
ECOG performance status (PS) score: 0～1;
The expected survi [...]
Secondary endpointsdetails revised at 4 of 4 entries
Study description-10 characters
The enrolled patients diagnosed with recurrent or refractory pediatric neuroblastoma received apatinib combined with IT regimen ch [...] as maintained at fixed doses, with patients receiving up to 68 cycles of chemotherapy.
The recommended Phase II dose (RP2D [...] combination with the IT regimen (at fixed doses) for up to 68 cycles.
In the maintenance therapy phase, apatinib was admi [...]
Study sitesdetails revised at 1 of 1 site
Study title-10 characters
Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
2026-02-04
minor
Study Identification, Study Status, Oversight v4
Primary completion dateestimated 2025-12-26→confirmed 2026-02-04
Completion date2025-12-30→2026-02-04
2025-04-13
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v3
PhasePhase 2→Phase 1/2
Enrollment target62→125
Study arms1→4
Study description+687 characters
[...] ma received apatinib combined with IT regimen chemotherapy, including phase I and phase II stage.
During the treatmentPhase includingI stage, apatinib was administered using a 3+3 dose escalation design with three dose cohorts.
The IT regimen was maintained at fixed doses, with patients receiving up to 6 cycles of chemotherapy.
The recommended Phase II dose (RP2D) was determined from the Phase I dose-escalation phase.
In the Phas [...] combination therapy phase and monotherapyan apatinib maintenance therapy phase.
During the combination therapy phase, apatinib was administered at the RP2D in combina [...]
Study title+56 characters
Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
2023-09-19
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-08-26→2025-12-26
Completion date2023-08-30→2025-12-30
Study sites0→1
2021-08-29
minor
Study Status, Conditions v1
Re-verified, no change to tracked fields
2021-08-24
minor
Original filing