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Ebastine for Adjuvant Treatment of Tumor Budding-Positive Liver Cancer After Surgery
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Summary
This study evaluates ebastine, an FAK (focal adhesion kinase) inhibitor, as adjuvant therapy to reduce the risk of recurrence in patients with hepatocellular carcinoma (HCC) who have undergone curative hepatectomy and whose tumors show a histopathological feature known as tumor budding, which is associated with a higher risk of postoperative recurrence. Ebastine is a second-generation antihistamine approved for allergic conditions. Preclinical studies have shown that ebastine also inhibits FAK signaling, a pathway implicated in tumor invasion, epithelial-mesenchymal transition, and recurrence. This study investigates whether administering ebastine after surgery can lower the recurrence risk associated with tumor budding-positive HCC. All enrolled participants will receive ebastine as adjuvant treatment following hepatectomy. The primary endpoint is the 1-year recurrence-free survival (RFS) rate. Secondary endpoints include 2-year RFS, overall survival, and safety. All participants in this study will receive ebastine as adjuvant (after-surgery) treatment. Researchers will monitor whether the cancer stays away for at least one year after surgery (recurrence-free survival), as well as overall survival and any side effects.
Official title: A Single-Arm Study of Ebastine as Adjuvant Therapy in Patients With Tumor Budding-Positive Hepatocellular Carcinoma After Curative Hepatectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-10-01
Completion Date
2030-03-01
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Ebastine
Ebastine will be administered orally at 20 mg once daily for 12 months as adjuvant therapy, beginning within 4 to 6 weeks after curative-intent hepatectomy in patients with histologically confirmed tumor budding-positive hepatocellular carcinoma.