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

Summary

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

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.

Conditions5

Interventions1

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