Simple gel may prevent painful side effect of liver cancer drug
NCT ID NCT07560566
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if applying a topical gel (indomethacin) to the hands before starting sorafenib can prevent or reduce hand-foot skin reactions, a common and painful side effect. About 39 adults with advanced liver cancer will use the gel twice daily for up to 12 weeks. The goal is to see if this simple approach helps patients stay on their cancer treatment with less discomfort.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Taiwan University Hospital
RECRUITINGTaipei, 10002, Taiwan
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