NCT07560566RecruitingPhase 2
SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 9 Dec 2025
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07560566
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From 9 Dec 2025 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.
- Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.
- Any concurrent systemic chemotherapy, immunotherapy, or biologic for cancer treatment.
- 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.
Other illness
- Known allergy to NSAID.
- Recent gastrointestinal bleeding within 12 weeks.
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.
Other
- Unresolved HFS.
- 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.
Who the study is looking for
- 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.
- Child-Pugh score A-B7.
- Sorafenib is deemed as an appropriate treatment option for the patient at the discretion of the investigator.
- 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.
- Willing and able to comply with the requirements and restrictions in this protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.