Ebastine for Adjuvant Treatment of Tumor Budding-Positive Liver Cancer After Surgery

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.

Inclusion Criteria: * 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; Exclusion Criteria: * 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; * Subjects who are considered unsuitable to participate in this cohort study by the investigator; * Subjects who refuse to enroll or do not sign the informed consent form; * Subjects with incomplete medical record information (including gender, age, diagnostic information, imaging (and) or pathological diagnosis results, other demographic data, etc.).