Hepato Cellular CarcinomaPhase 4NCT07734766
Ebastine for Adjuvant Treatment of Tumor Budding-Positive Liver Cancer After Surgery
A Phase 4 study testing Ebastine in people with Hepato Cellular Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma
- What is being tested?
- Ebastine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Mar 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Study of Ebastine as Adjuvant Therapy in Patients With Tumor Budding-Positive Hepatocellular Carcinoma After Curative Hepatectomy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hepato Cellular Carcinoma
- Being tested
- Ebastine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbastineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ebastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after surgery
Secondary outcomes (3)
2-Year Recurrence-Free Survival (RFS) Rate
Proportion of participants free of recurrence or death from any cause at 2 years after curative hepatectomy
Measured: 2 years after surgery
Overall Survival (OS)
Time from surgery to death from any cause
Measured: 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]
Measured: From first dose of ebastine through 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734766
- Sponsor's protocol ID
- XJTUSAH-TB-Z009
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Study of Ebastine as Adjuvant Therapy in Patients With Tumor Budding-Positive Hepatocellular Carcinoma After Curative Hepatectomy
- ClinicalTrials.gov ID
- NCT07734766
- Acronym / sponsor ID
- XJTUSAH-TB-Z009
- Conditions
- Hepato Cellular Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ebastine Adjuvant Treatment Arm | Experimental | Drug: EbastineParticipants with tumor budding-positive hepatocellular carcinoma who have undergone curative-intent hepatectomy will receive oral ebastine as adjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EbastineEbastine 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. | Drug | Ebastine Adjuvant Treatment Arm |
Primary outcome
1-Year Recurrence-Free Survival (RFS) Rate
Time frame: 1 year after surgery
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
3 secondary outcomes
2-Year Recurrence-Free Survival (RFS) Rate
Time frame: 2 years after surgery
Overall Survival (OS)
Time frame: Through study completion, approximately 3 years
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose of ebastine through 30 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ebastine in people with Hepato Cellular Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Recurrence-Free Survival (RFS) Rate (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.