Pre-emptive topical indomethacin to prevent sorafenib-related hand-foot syndrome in advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SHIELD is a single-center, open-label, single-arm Phase 2 study enrolling 39 adults with advanced hepatocellular carcinoma who are planned to start sorafenib. Participants will apply 1% topical indomethacin gel to the palmar and dorsal surfaces of both hands twice daily (up to 4 g/day) while receiving standard sorafenib dosing for up to 12 weeks or until hand-foot syndrome develops or sorafenib is discontinued. The primary endpoint is the incidence of all-grade hand-foot syndrome during the first 12 weeks; secondary endpoints include rates of grade ≥2 and grade ≥3 HFS, mean sorafenib dose intensity, adverse events of special interest, and duration of sorafenib treatment. Outcomes will be compared with historical control data to estimate whether prophylactic topical indomethacin lowers HFS rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Yu-Yun Shao, M.D., Ph.D. — National Taiwan University Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.