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.
Age is ≥18 years old, male or female;
Histologically confirmed as hepatocellular carcinoma without metastasis;
Tumor budding is positive
Life expectancy of at least 12 weeks;
Hepatocellular carcinoma that cannot be surgically resected
Received radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. before surgery
Pregnant or lactating women
Subjects with other malignant tumors;
Single group
Ebastine
DrugEbastine 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.
1-Year Recurrence-Free Survival (RFS) Rate
Proportion of participants who remain free of tumor recurrence (local, regional, or distant) or death from any cause at 1 year after curative hepatectomy, as assessed by imaging (CT/MRI) per institutional standard follow-up protocol
2-Year Recurrence-Free Survival (RFS) Rate
Proportion of participants free of recurrence or death from any cause at 2 years after curative hepatectomy
Overall Survival (OS)
Time from surgery to death from any cause
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events), version \[5.0\]
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