SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
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% 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or male patients, 18 years of age or older, able to understand and give written informed consent.
Hepatocellular carcinoma, diagnosed by clinical or pathological diagnosis.
Patients with advanced HCC, defined as those with macrovascular invasion, extrahepatic spread, or who failed or are not feasible to locoregional therapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Disqualifiers
Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.
Unresolved HFS.
Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.
Known allergy to NSAID.
Trial design
Design model
Single group
Treatments tested in this trial
Topical Indomethacin
DrugThe participant will be provided with 2 tubes (20 gm each) per week in the first 4 weeks (D1, 8, 15, 22), 4 tubes per 2 weeks at the second 4 weeks (D29, 43), and 4 tubes per 4 weeks for the third 4 weeks (D57) suffice for topical application over 12 weeks. The participant will apply 1 g (1 g = two fingertip units \[FTU\]: one FTU for one surface of one hand) of 1% topical indomethacin on the palmar and dorsal surface of each hand twice daily (= 4g/day) until discontinuation of sorafenib or 12 weeks or development of HFS, whichever is earlier. If the patient has adequate residual indomethacin gel at the visit, the prescribing amount may be reduced accordingly.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
All-grade hand-foot skin reaction rate during the first 12 weeks of sorafenib treatment
The proportion of participants who experience any grade of hand-foot skin reaction during the first 12 weeks of sorafenib treatment. Hand-foot skin reaction severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The grading scale ranges from Grade 1 to Grade 5, with higher grades indicating greater severity. For participants who discontinue sorafenib before Week 12, hand-foot skin reaction events will be assessed during the actual sorafenib treatment period.
Time frame
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.Secondary outcomes
1
Grade ≥2 hand-foot skin reaction rate during the first 12 weeks
The proportion of participants who experience Grade 2 or higher hand-foot skin reaction during the first 12 weeks of sorafenib treatment. Hand-foot skin reaction severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The grading scale ranges from Grade 1 to Grade 5, with higher grades indicating greater severity.
Time frame
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.2
Grade ≥3 hand-foot skin reaction rate during the first 12 weeks
The proportion of participants who experience Grade 3 or higher hand-foot skin reaction during the first 12 weeks of sorafenib treatment. Hand-foot skin reaction severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The grading scale ranges from Grade 1 to Grade 5, with higher grades indicating greater severity.
Time frame
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.3
Mean sorafenib dose intensity during the first 12 weeks of treatment
Time frame
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.4
Adverse events of special interest in the first 12 weeks of sorafenib treatment
Time frame
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov