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

Recruiting Phase 2 Interventional Study
Hepato Cellular Carcinoma (HCC) Hand Foot Skin Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
39 (estimated)
Sponsor
National Taiwan University Hospital · Other
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About This Trial
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% top…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Female or male patients, 18 years of age or older, able to understand and give written informed consent. 2. Hepatocellular carcinoma, diagnosed by clinical or pathological diagnosis. 3. Patients with advanced HCC, defined as those with macrovascular invasion, extrahepatic spr…
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