Pre-emptive topical indomethacin to prevent sorafenib-related hand-foot syndrome in advanced liver cancer
SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
This trial will test whether applying 1% indomethacin gel to both hands twice daily can reduce hand-foot syndrome in adults with advanced hepatocellular carcinoma starting sorafenib.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07560566 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with advanced hepatocellular carcinoma who are planning to start sorafenib, have ECOG performance status ≤2, Child-Pugh A–B7, and can apply topical medication and attend study visits.
Not a fit: Patients with unresolved pre-existing hand-foot syndrome, recent exposure to other multikinase inhibitors or capecitabine, significant uncontrolled liver dysfunction beyond Child-Pugh B7, or inability to use topical therapy may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the frequency or severity of sorafenib-related hand-foot syndrome, helping patients stay on treatment longer and maintain quality of life.
How similar studies have performed: Topical NSAIDs have shown preventive activity against chemotherapy-related hand-foot syndrome in prior studies, but pre-emptive indomethacin specifically for sorafenib-associated HFS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yu-Yun Shao, M.D., Ph.D. — National Taiwan University Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.