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

NCT07734766 | Not Yet Recruiting Phase 4

• 1 other identifier: XJTUSAH-TB-Z009
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepato Cellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  1 year after surgery

Secondary Outcomes (3)

• 2-Year Recurrence-Free Survival (RFS) Rate

  2 years after surgery

• Overall Survival (OS)

  Through study completion, approximately 3 years

• Incidence of Treatment-Emergent Adverse Events

  From first dose of ebastine through 30 days after last dose

Study Arms (1)

Ebastine Adjuvant Treatment Arm

EXPERIMENTAL

Participants with tumor budding-positive hepatocellular carcinoma who have undergone curative-intent hepatectomy will receive oral ebastine as adjuvant therapy.

Drug: Ebastine

Interventions

Ebastine DRUG

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.

Ebastine Adjuvant Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Interventions

ebastine

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07