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Study identifier: NCT07560566 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin

Condition: Hepato Cellular Carcinoma (HCC) · Hand Foot Skin Syndrome  ·  Sponsor: National Taiwan University Hospital

PhasePhase 2
Planned participants39
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

SHIELD is a single-center, open-label, single-arm prospective study designed to evaluate whether pre-emptive topical indomethacin can reduce sorafenib-associated hand-foot syndrome (HFS) in patients with advanced hepatocellular carcinoma (HCC). Eligible adult patients with advanced HCC who are planned to initiate sorafenib will receive standard sorafenib treatment together with prophylactic 1% topical indomethacin gel applied to both hands twice daily for up to 12 weeks, or until development of HFS or discontinuation of sorafenib, whichever occurs first. The primary endpoint is the incidence of all-grade HFS during the first 12 weeks of sorafenib treatment. Secondary endpoints include grade 2 or higher HFS rate, grade 3 or higher HFS rate, mean sorafenib dose intensity during the first 12 weeks, adverse events of special interest, and duration of sorafenib treatment. The study will enroll 39 patients and compare outcomes with historical control data.

This description comes directly from the study's public registry record.

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Locations (1)

National Taiwan University HospitalTaipei, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT07560566