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NOT YET RECRUITING
NCT07734766
PHASE4

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

Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.