About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Ebastine