Last reviewed · How we verify
NCT05519917
Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma
Phase 2 trial testing Afatinib in Chordoma of Clivus in 20 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | Huashan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 October 2022 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Afatinib (afatinib) — full drug profile →
Conditions studied
- Chordoma of Clivus — all drugs for Chordoma of Clivus →
Sponsor
Huashan Hospital
Who can join
18 and older, any sex, with Chordoma of Clivus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single arm, open label, single center, and prospective, interventional study to explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull base by objective response rate (ORR). The Secondary objectives is to assess progression free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage degree in patients with chordoma of skull base after using afatinib; to evaluate the safety and tolerability of afatinib in patients with chordoma of skull base.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Integrated Molecular and Histological Insights for Targeted Therapies in Mesenchymal Sinonasal Tract Tumors.
Hoch CC, Knoedler L, Knoedler S, Bashiri Dezfouli A, et al · · 2024 · PMID 38376625 · DOI 10.1007/s11912-024-01506-9
Verify or expand the search:
- PubMed search for NCT05519917
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Afatinib
Trials testing the same drug.
- NCT07040956 — A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neo · Phase 2 · recruiting
- NCT07010120 — A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head · Phase 1, PHASE2 · recruiting
- NCT06804850 — Neoadjuvant Radiotherapy Plus Targeted Therapy and Immunotherapy vs. Targeted Therapy Plus Immunotherapy in Resectable H · Phase 2 · withdrawn
- NCT06741982 — A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy an · Phase 1 · recruiting
- NCT06494189 — Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable · Phase 1 · completed
Other Huashan Hospital trials
Trials by the same sponsor.
- NCT07469735 — Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma · NA · not yet recruiting
- NCT07364487 — This is an Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Multiple Sclerosis · EARLY_PHASE1 · withdrawn
- NCT07369830 — The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function · NA · recruiting
- NCT07185373 — Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL · Phase 2, PHASE3 · not yet recruiting
- NCT07075029 — RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China · 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 NCT05519917 (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 Huashan Hospital
- Last refreshed: 30 September 2022
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/NCT05519917.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing