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NCT07137884: ALTER-02
Anlotinib Hydrochloride Capsules in Maintenance Treatment for Intermediate-High Risk Rhabdomyosarcoma in Children
Phase 2 trial testing Anlotinib+Cyclophosphamide+Vinorelbine in Rhabdomyosarcoma Recurrent in 150 participants. Not yet recruiting.
30 October 2028
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 October 2025 |
| Primary completion | 30 October 2028 |
| Estimated completion | 30 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib+Cyclophosphamide+Vinorelbine — full drug profile →
- Cyclophosphamide+Vinorelbine — full drug profile →
Conditions studied
- Rhabdomyosarcoma Recurrent — all drugs for Rhabdomyosarcoma Recurrent →
- Maintenance Treatment — all drugs for Maintenance Treatment →
Sponsor
Sun Yat-sen University
Who can join
Adults 5 to 18, any sex, with Rhabdomyosarcoma Recurrent or Maintenance Treatment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized controlled phase II clinical study aimed at evaluating the efficacy and safety of anlotinib hydrochloride in children with Intermediate-High -risk rhabdomyosarcoma. The study enrolled children with rhabdomyosarcoma confirmed by histopathology, with a clinical risk classification of high or Intermediate-risk accompanied by high-risk factors (high-risk factors are defined as age \> 10 years，Poor prognosis molecular characteristics or those who cannot undergo surgery/radiotherapy);One year of maintenance treatment with anlotinib can increase the duration of response and long-term survival.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07137884
- Europe PMC full search
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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 NCT07137884 (US National Library of Medicine, public domain)
- 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: 22 August 2025
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/NCT07137884.
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