Hepatocellular Carcinoma (HCC)Phase 1NCT07077356
Application of mRNA Vaccine in Liver Transplantation for Hepatocellular Carcinoma
A Phase 1 study testing HBV mRNA vaccine in people with Hepatocellular Carcinoma (HCC), run by West China Hospital at 1 site in China.
Trial summary
The therapeutic options for HCC include hepatectomy, liver transplantation, local ablation therapy, transarterial chemoembolization (TACE), radiotherapy, and systemic therapy. However, as early-stage HCC often presents with no obvious symptoms or atypical clinical manifestations, over 80% of patients are diagnosed at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- HBV mRNA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Phase 1
- 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
- Male or female patients aged ≥18 years;
- Patients with histologically, cytologically, or clinically diagnosed hepatocellular carcinoma (HCC);
- Patients who, based on the investigator's assessment, meet the indications for liver transplantation and have expressed willingness to undergo transplantation, with a need for bridge therapy or downstaging therapy during the transplant waiting period as evaluated by the investigator;
- Positive for hepatitis B surface antigen (HBsAg) in peripheral blood;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2; (Additional inclusion criteria may be supplemented.)
Who cannot join
- History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;
- History of or current hepatic encephalopathy; known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;
- Clinically significant ascites requiring therapeutic intervention at present;
- Known clinically significant uncontrolled cardiac symptoms or diseases;
- Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin); (Additional exclusion criteria may be supplemented.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu
Li, +86 19940598063, snowkudo@163.com
About this study
The therapeutic options for HCC include hepatectomy, liver transplantation, local ablation therapy, transarterial chemoembolization (TACE), radiotherapy, and systemic therapy. However, as early-stage HCC often presents with no obvious symptoms or atypical clinical manifestations, over 80% of patients are diagnosed at an advanced stage, losing the opportunity for surgical resection and leaving liver transplantation as the only potentially curative option. Nevertheless, even after liver transplantation, the recurrence rate of HCC remains as high as 30-45%. In recent years, with the successive launch of novel targeted drugs and immune checkpoint inhibitors, Chinese patients with HCC have gained more treatment options for both disease management and recurrence prevention. However, given the heterogeneity of HCC, only a subset of patients benefit from these therapies.
Hepatitis B virus (HBV) infection is the primary risk factor for HCC, accounting for at least 50% of global HCC cases. In regions with high HBV prevalence-such as East and Southeast Asia, as well as sub-Saharan Africa-the proportion is even higher. While HBV-related HCC can be prevented through vaccination against HBV infection, no specific precision therapy currently exists for patients already diagnosed with HBV-positive HCC. Given that nucleic acid vaccine technology demonstrates value not only in disease prevention but also in immunotherapy-particularly mRNA therapeutic vaccines-this approach holds promise.
mRNA therapeutic vaccines represent a highly promising new modality for tumor treatment. They offer advantages such as excellent safety, long-term expression, and sustained antigen presentation. Additionally, they can mimic the natural infection process of viruses to activate the immune system, eliciting robust immune responses against tumors. Currently, no mRNA therapeutic vaccines targeting HBV-related antigens have been approved for marketing. This HBV mRNA injection is an mRNA therapeutic vaccine encoding HBV-related specific antigens. Its active ingredient consists of modified mRNA encoding HBV-related antigen proteins, formulated into an injectable preparation via lipid nanoparticle (LNP) encapsulation. Preclinical safety evaluations have demonstrated that this vaccine exhibits low toxicity and good tolerability. Building on these preliminary results, this study aims to further evaluate its potential.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- HBV mRNA vaccine
- Keywords
- Hepatocellular Carcinoma, Liver Transplantation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV mRNA vaccineBiological
HBV mRNA vaccine
| Study group | Role | What they receive |
|---|---|---|
| HBV mRNA vaccine, Dose 1 | Experimental | Not described Receives: Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 2 | Experimental | Not described Receives: Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 3 | Experimental | Not described Receives: Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 4 | Experimental | Not described Receives: Biological: HBV mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) and their incidence rates
Measured: During one year after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events as assessed by CTCAE V5.0
Measured: During one year after initial treatment
Secondary outcomes (4)
Objective response rate (ORR)
Measured: During one year after initial treatment
Disease control rate (DCR)
Measured: During one year after initial treatment
1-year survival rate
Measured: During one year after initial treatment
Immunogenicity: The level of antigen-specific T cells
Measured: During one year after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyan Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077356
- Sponsor's protocol ID
- HBV mRNA-Liver Tx
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of mRNA Vaccine in Liver Transplantation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07077356
- Acronym / sponsor ID
- HBV mRNA-Liver Tx
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, Liver Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 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.
The therapeutic options for HCC include hepatectomy, liver transplantation, local ablation therapy, transarterial chemoembolization (TACE), radiotherapy, and systemic therapy. However, as early-stage HCC often presents with no obvious symptoms or atypical clinical manifestations, over 80% of patients are diagnosed at an advanced stage, losing the opportunity for surgical resection and leaving liver transplantation as the only potentially curative option. Nevertheless, even after liver transplantation, the recurrence rate of HCC remains as high as 30-45%. In recent years, with the successive launch of novel targeted drugs and immune checkpoint inhibitors, Chinese patients with HCC have gained more treatment options for both disease management and recurrence prevention. However, given the heterogeneity of HCC, only a subset of patients benefit from these therapies.
Hepatitis B virus (HBV) infection is the primary risk factor for HCC, accounting for at least 50% of global HCC cases. In regions with high HBV prevalence-such as East and Southeast Asia, as well as sub-Saharan Africa-the proportion is even higher. While HBV-related HCC can be prevented through vaccination against HBV infection, no specific precision therapy currently exists for patients already diagnosed with HBV-positive HCC. Given that nucleic acid vaccine technology demonstrates value not only in disease prevention but also in immunotherapy-particularly mRNA therapeutic vaccines-this approach holds promise.
mRNA therapeutic vaccines represent a highly promising new modality for tumor treatment. They offer advantages such as excellent safety, long-term expression, and sustained antigen presentation. Additionally, they can mimic the natural infection process of viruses to activate the immune system, eliciting robust immune responses against tumors. Currently, no mRNA therapeutic vaccines targeting HBV-related antigens have been approved for marketing. This HBV mRNA injection is an mRNA therapeutic vaccine encoding HBV-related specific antigens. Its active ingredient consists of modified mRNA encoding HBV-related antigen proteins, formulated into an injectable preparation via lipid nanoparticle (LNP) encapsulation. Preclinical safety evaluations have demonstrated that this vaccine exhibits low toxicity and good tolerability. Building on these preliminary results, this study aims to further evaluate its potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HBV mRNA vaccine, Dose 1 | Experimental | Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 2 | Experimental | Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 3 | Experimental | Biological: HBV mRNA vaccine |
| HBV mRNA vaccine, Dose 4 | Experimental | Biological: HBV mRNA vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged ≥18 years;
- Patients with histologically, cytologically, or clinically diagnosed hepatocellular carcinoma (HCC);
- Patients who, based on the investigator's assessment, meet the indications for liver transplantation and have expressed willingness to undergo transplantation, with a need for bridge therapy or downstaging therapy during the transplant waiting period as evaluated by the investigator;
- Positive for hepatitis B surface antigen (HBsAg) in peripheral blood;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2; (Additional inclusion criteria may be supplemented.)
Key exclusion criteria (5 listed)
- History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;
- History of or current hepatic encephalopathy; known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;
- Clinically significant ascites requiring therapeutic intervention at present;
- Known clinically significant uncontrolled cardiac symptoms or diseases;
- Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin); (Additional exclusion criteria may be supplemented.)
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 |
|---|---|---|
| HBV mRNA vaccineHBV mRNA vaccine | Biological | HBV mRNA vaccine, Dose 1, HBV mRNA vaccine, Dose 2, HBV mRNA vaccine, Dose 3, HBV mRNA vaccine, Dose 4 |
Primary outcome
Dose-limiting toxicities (DLTs) and their incidence rates
Time frame: During one year after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events as assessed by CTCAE V5.0
Time frame: During one year after initial treatment
4 secondary outcomes
Objective response rate (ORR)
Time frame: During one year after initial treatment
Disease control rate (DCR)
Time frame: During one year after initial treatment
1-year survival rate
Time frame: During one year after initial treatment
Immunogenicity: The level of antigen-specific T cells
Time frame: During one year after initial treatment
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 22 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBV mRNA vaccine in people with Hepatocellular Carcinoma (HCC), run by West China Hospital at 1 site in China.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) and their incidence rates (time frame: During one year after initial treatment). The study lists 2 primary outcomes in all. 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 22 Jul 2025.