Carcinoma, HepatocellularPhase 4NCT07160361
Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB
A Phase 4 study testing Lenvatinib + losartan in people with Carcinoma, Hepatocellular, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
Hepatocellular carcinoma (HCC) is one of the most common types of primary liver cancer worldwide, characterized by complex and variable disease progression and significant treatment challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Lenvatinib + losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2029
- 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: Exploration of Postoperative Adjuvant Therapy for Hepatocellular Carcinoma Patients With Positive Tumor Budding
Hepatocellular carcinoma (HCC) is one of the most common types of primary liver cancer worldwide, characterized by complex and variable disease progression and significant treatment challenges. Among HCC patients, tumor budding (TB) is associated with a high risk of postoperative recurrence, significantly impacting patient prognosis. Even in the current HCC pathological diagnosis "gold standard" of MVI-negative patients, TB retains excellent prognostic predictive value. TB cells reside within the peritumoral stroma, where dense collagen fibers restrict the efficacy of therapeutic agents including chemotherapy, immunotherapy, and targeted therapies, making it difficult for single-agent treatments to effectively eliminate TB. Therefore, specific treatment strategies should be considered for TB-positive patients to improve survival outcomes and reduce the risk of tumor recurrence. To address this clinical challenge, this study aims to clarify the prognostic impact of combining collagen degradation therapy with targeted therapy in TB-positive HCC patients. Through a single-arm trial (postoperative targeted therapy + collagen degradation therapy), investigators explore the clinical efficacy and prognostic indicators of this combination approach, seeking the optimal treatment strategy for TB-positive HCC patients. Collagen degradation therapy facilitates drug delivery to tumor-bottle lesions by degrading collagen barriers, while targeted therapy specifically intervenes against cancer cells. Their combination holds promise for synergistic effects and enhanced therapeutic outcomes. This study aims to preliminarily assess the impact of this dual approach on prognosis, providing evidence for personalized treatment strategies. The findings of this research hold promise for delivering new breakthroughs in the treatment of TB-positive HCC patients, improving their quality of life and survival rates, and providing robust support for future clinical practice.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Lenvatinib + losartan
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib + losartanDrug
Patients will receive a combination of lenvatinib and losartan at the same time after surgery for treatment cycles once daily (lenvatinib and losartan).
Adjuvant therapy will be started within 2-6 weeks after surgery for a period of time to evaluate the effect of different treatment regimens on reducing tumor recurrence and improving survival.
lenvatinib: orally once daily according to standard dosing guidelines, starting postoperatively.
losartan: 50mg losartan potassium tablets orally once daily starting postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib + losartan treatment group | Experimental | Not described Receives: Drug: Lenvatinib + losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate within 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Affiliated Hospital of Qinghai University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160361
- Sponsor's protocol ID
- XJTUSAH-TB-Z008
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Postoperative Adjuvant Therapy for Hepatocellular Carcinoma Patients With Positive Tumor Budding
- ClinicalTrials.gov ID
- NCT07160361
- Acronym / sponsor ID
- XJTUSAH-TB-Z008
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Affiliated Hospital of Qinghai University
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Sep 2025 (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.
Hepatocellular carcinoma (HCC) is one of the most common types of primary liver cancer worldwide, characterized by complex and variable disease progression and significant treatment challenges. Among HCC patients, tumor budding (TB) is associated with a high risk of postoperative recurrence, significantly impacting patient prognosis. Even in the current HCC pathological diagnosis "gold standard" of MVI-negative patients, TB retains excellent prognostic predictive value. TB cells reside within the peritumoral stroma, where dense collagen fibers restrict the efficacy of therapeutic agents including chemotherapy, immunotherapy, and targeted therapies, making it difficult for single-agent treatments to effectively eliminate TB. Therefore, specific treatment strategies should be considered for TB-positive patients to improve survival outcomes and reduce the risk of tumor recurrence. To address this clinical challenge, this study aims to clarify the prognostic impact of combining collagen degradation therapy with targeted therapy in TB-positive HCC patients. Through a single-arm trial (postoperative targeted therapy + collagen degradation therapy), investigators explore the clinical efficacy and prognostic indicators of this combination approach, seeking the optimal treatment strategy for TB-positive HCC patients. Collagen degradation therapy facilitates drug delivery to tumor-bottle lesions by degrading collagen barriers, while targeted therapy specifically intervenes against cancer cells. Their combination holds promise for synergistic effects and enhanced therapeutic outcomes. This study aims to preliminarily assess the impact of this dual approach on prognosis, providing evidence for personalized treatment strategies. The findings of this research hold promise for delivering new breakthroughs in the treatment of TB-positive HCC patients, improving their quality of life and survival rates, and providing robust support for future clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib + losartan treatment group | Experimental | Drug: Lenvatinib + losartan |
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 |
|---|---|---|
| Lenvatinib + losartanPatients will receive a combination of lenvatinib and losartan at the same time after surgery for treatment cycles once daily (lenvatinib and losartan). Adjuvant therapy will be started within 2-6 weeks after surgery for a period of time to evaluate the effect of different treatment regimens on reducing tumor recurrence and improving survival. lenvatinib: orally once daily according to standard dosing guidelines, starting postoperatively. losartan: 50mg losartan potassium tablets orally once daily starting postoperatively. | Drug | Lenvatinib + losartan treatment group |
Primary outcome
Relapse rate within 2 years
Time frame: 2 years
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 16 Sep 2025.
Related trials for Carcinoma, Hepatocellular
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 Lenvatinib + losartan in people with Carcinoma, Hepatocellular, 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 16 Sep 2025. 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?
Relapse rate within 2 years (time frame: 2 years). 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 16 Sep 2025.