A Phase 4 interventional study of Ebastine in Hepato Cellular Carcinoma, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Phase 4, Interventional, and Treatment
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.
Hepatocellular carcinoma (HCC) remains associated with a high rate of recurrence following curative hepatectomy, and tumor budding-a histopathological feature characterized by isolated single cells or small clusters of tumor cells at the invasive front-has been increasingly recognized as an independent adverse prognostic factor associated with epithelial-mesenchymal transition (EMT), local invasion, and early recurrence in multiple solid tumors, including HCC.
Focal adhesion kinase (FAK) is a non-receptor tyrosine kinase that plays a central role in tumor cell adhesion, migration, invasion, and the EMT process that underlies tumor budding. FAK is frequently overexpressed and hyperactivated in HCC tissue and has been implicated in promoting a fibrotic, immunosuppressive tumor microenvironment that supports tumor progression and treatment resistance.
Ebastine, a second-generation H1-antihistamine widely used for allergic rhinitis and urticaria with a well-characterized long-term safety profile, has recently been identified through drug-repurposing research as a small-molecule inhibitor of FAK. Preclinical studies have demonstrated that ebastine binds the tyrosine kinase domain of FAK, blocking autophosphorylation at Y397 and Y576/577 residues, thereby attenuating downstream FAK-mediated signaling (including JAK2/STAT3 and MEK/ERK pathways) that drives tumor stem-cell-like properties, invasion, and metastasis in several solid tumor models, including triple-negative and HER2-positive breast cancer.
Given the mechanistic link between FAK signaling and tumor budding, and the favorable safety and tolerability profile of ebastine at its approved dose range, this study proposes to evaluate ebastine as an adjuvant therapy specifically in patients with tumor budding-positive HCC following curative hepatectomy-a population at elevated risk of early recurrence for whom effective, well-tolerated adjuvant options remain limited.
Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with tumor budding-positive hepatocellular carcinoma who have undergone curative-intent hepatectomy will receive oral ebastine as adjuvant therapy.
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.
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
Time frame: 1 year after surgery
2-Year Recurrence-Free Survival (RFS) Rate
Proportion of participants free of recurrence or death from any cause at 2 years after curative hepatectomy
Time frame: 2 years after surgery
Overall Survival (OS)
Time from surgery to death from any cause
Time frame: Through study completion, approximately 3 years
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events), version \[5.0\]
Time frame: From first dose of ebastine through 30 days after last dose
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Mar 2029, 29 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ebastine
Second Affiliated Hospital of Xi'an Jiaotong University