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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

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

Treatment groups

45 Participants
are divided into 1 treatment group

Locations

This trial has no locations