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SHIELD: Topical Indomethacin for Sorafenib-associated Hand-foot Syndrome in HCC
NCT07560566Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2025
- Primary completion
- Apr 2029
- Countries
- 1
- Sponsor
- National Taiwan University Hospital
- Modality
- Small Molecules
- Drugs
- indomethacin
- Conditions
- hand-foot syndrome (HFS)
01
Overview
Phase 2, open-label, single-arm trial of indomethacin in hand-foot syndrome (HFS), sponsored by National Taiwan University Hospital. Primary endpoint: All-grade hand-foot skin reaction rate at 12 weeks. Started Dec 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Experimental
Prophylactic topical indomethacin + Sorafenib
03
Who it enrols
Adult patients with advanced hepatocellular carcinoma planned to initiate sorafenib, with ECOG <= 2 and Child-Pugh A-B7.
04
Endpoints
Primary
All-grade hand-foot skin reaction rate
Secondary
Grade >=2 hand-foot skin reaction rate
Grade >=3 hand-foot skin reaction rate
Mean sorafenib dose intensity
Adverse events of special interest
Treatment duration of sorafenib
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