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New treatment option for Hepato Cellular Carcinoma (HCC)
Official title SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
ClinicalTrials.gov ID: NCT07560566
What this study is testing
What is Topical Indomethacin?
Topical Indomethacin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepato cellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Child-Pugh score A-B7.
You likely can't join if
- Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.
- Unresolved HFS.
- Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.
- Known allergy to NSAID.
- Any concurrent systemic chemotherapy, immunotherapy, or biologic for cancer treatment.
- Recent gastrointestinal bleeding within 12 weeks.
See the full eligibility criteria
- 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 people and female people 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.
- Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.
- Unresolved HFS.
- Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.
- Known allergy to NSAID.
- Any concurrent systemic chemotherapy, immunotherapy, or biologic for cancer treatment.
- Recent gastrointestinal bleeding within 12 weeks.
- 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.
- 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.
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.