Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07560566

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

Led by National Taiwan University Hospital · Updated on 2026-05-01

39

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, able to understand and provide written informed consent
  • Diagnosis of hepatocellular carcinoma by clinical or pathological methods
  • Advanced HCC with macrovascular invasion, extrahepatic spread, or failure/infeasibility of locoregional therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Child-Pugh liver function score of A to B7
  • Sorafenib considered an appropriate treatment option by the investigator
  • Agreement to use protocol-specified contraception if of childbearing potential and sexually active
  • Willingness and ability to comply with study requirements and restrictions
Not Eligible

You will not qualify if you...

  • Use of multikinase inhibitors or capecitabine within 1 week before starting study treatment
  • Presence of unresolved hand-foot syndrome
  • Use of oral NSAIDs, topical NSAIDs, or topical steroids within 1 week before starting study treatment
  • Known allergy to NSAIDs
  • Receiving other systemic chemotherapy, immunotherapy, or biologic cancer treatments
  • Recent gastrointestinal bleeding within the past 12 weeks
  • Pregnancy, breastfeeding, or not using effective birth control if of reproductive potential
  • Other medical or psychiatric conditions that may interfere with study participation or follow-up
  • Any condition posing undue risk to participation as judged by the investigator or sponsor

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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