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NCT05027386
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.
Phase 1, PHASE2 trial testing Apatinib, Irinotecan, Temozolomide in Neuroblastoma in 125 participants. Currently enrolling.
4 February 2026
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 26 August 2021 |
| Primary completion | 4 February 2026 |
| Estimated completion | 4 February 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Apatinib, Irinotecan, Temozolomide — full drug profile →
Conditions studied
- Neuroblastoma — all drugs for Neuroblastoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 5 to 18, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor. Apatinib mesylate has been shown to be safe and effective in recurrent or refractory pediatric neuroblastoma in Sun Yat-sen University Cancer Center. Apatinib mesylate combined with IT regimen is expected to further improve the efficacy and survival rate of recurrent or refractory pediatric neuroblastoma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biological Insight and Recent Advancement in the Treatment of Neuroblastoma.
Rivera Z, Escutia C, Madonna MB, Gupta KH. · · 2023 · cited 18× · PMID 37239815 · DOI 10.3390/ijms24108470
Verify or expand the search:
- PubMed search for NCT05027386
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neuroblastoma
Currently open trials in the same condition.
- NCT07399821 — An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma · Phase 1, PHASE2 · recruiting
- NCT06995872 — Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refra · Phase 1 · recruiting
- NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
- NCT07067346 — Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma · EARLY_PHASE1 · recruiting
- NCT07027748 — Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or R · Phase 1 · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05027386 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 5 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05027386.
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