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

27 aprile 2026 aggiornato da: National Taiwan University Hospital
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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a single-center, open-label, single-arm prospective study evaluating the prophylactic use of topical indomethacin for prevention of sorafenib-associated hand-foot syndrome (HFS) in patients with advanced hepatocellular carcinoma (HCC). Sorafenib is an established systemic treatment option for advanced HCC, but HFS is a frequent toxicity that may reduce quality of life and interfere with treatment delivery. Historical studies have reported all-grade HFS rates of approximately 45% in patients treated with sorafenib.

Topical NSAIDs have shown preventive activity against chemotherapy-related HFS in prior studies. Based on this rationale, this study will investigate whether pre-emptive administration of 1% topical indomethacin gel can reduce the incidence of sorafenib-related HFS while avoiding the systemic adverse effects associated with oral NSAIDs.

Eligible adult patients with advanced HCC who are planned to start sorafenib will receive sorafenib at an initial dose of 400 mg orally twice daily, with subsequent dose modification according to routine clinical practice. Participants will also apply 1% topical indomethacin gel to the palmar and dorsal surfaces of both hands twice daily (total 4 g/day) 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, defined according to NCI CTCAE version 5.0. Secondary endpoints include the incidence of grade 2 or higher HFS, incidence of grade 3 or higher HFS, mean sorafenib dose intensity during the first 12 weeks, adverse events of special interest, and sorafenib treatment duration. A total of 39 patients will be enrolled. Outcomes will be interpreted against historical control data.

Tipo di studio

Interventistico

Iscrizione (Stimato)

39

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan, 10002
        • Reclutamento
        • National Taiwan University Hospital
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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 spread, or who failed or are not feasible to locoregional therapy.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  5. Child-Pugh score A-B7.
  6. Sorafenib is deemed as an appropriate treatment option for the patient at the discretion of the investigator.
  7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendices.
  8. Willing and able to comply with the requirements and restrictions in this protocol.

Exclusion Criteria:

  1. Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.
  2. Unresolved HFS.
  3. Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.
  4. Known allergy to NSAID.
  5. Any concurrent systemic chemotherapy, immunotherapy, or biologic for cancer treatment.
  6. Recent gastrointestinal bleeding within 12 weeks.
  7. Female patients who are pregnant, breast-feeding, or male or female patients of reproductive potential who are not employing an effective method of birth control.
  8. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
  9. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental
Prophylactic topical indomethacin
Droga: Topical Indomethacin
The 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-grade hand-foot skin reaction rate during the first 12 weeks of sorafenib treatment
Lasso di tempo: From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
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.
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Grade ≥2 hand-foot skin reaction rate during the first 12 weeks
Lasso di tempo: From initiation of sorafenib treatment through Week 12, assessed up to 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.
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
Grade ≥3 hand-foot skin reaction rate during the first 12 weeks
Lasso di tempo: From initiation of sorafenib treatment through Week 12, assessed up to 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.
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
Mean sorafenib dose intensity during the first 12 weeks of treatment
Lasso di tempo: From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
Adverse events of special interest in the first 12 weeks of sorafenib treatment
Lasso di tempo: From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
From initiation of sorafenib treatment through Week 12, assessed up to 12 weeks.
Treatment duration of sorafenib
Lasso di tempo: From initiation of sorafenib treatment until permanent discontinuation of sorafenib, assessed up to 24 weeks.
From initiation of sorafenib treatment until permanent discontinuation of sorafenib, assessed up to 24 weeks.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Taiwan University Hospital

Investigatori

  • Investigatore principale: Yu-Yun Shao, M.D., Ph.D., National Taiwan University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 dicembre 2025

Completamento primario (Stimato)

30 aprile 2029

Completamento dello studio (Stimato)

30 aprile 2029

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202508066MIPC

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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