Hepatocellular Carcinoma (HCC)Phase 1NCT07077369
WGc-0201 Plus Tislelizumab in HCC With High Risk of Recurrence and Metastasis After Radical Therapy
A Phase 1 study testing WGc-0201 injection and Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by West China Hospital.
Trial summary
urgical treatment represents a critical approach for HCC patients to achieve long-term survival, primarily including hepatectomy and liver transplantation. With the increasing implementation of HCC screening in China, the proportion of patients eligible for curative-intent surgical resection or ablation has risen… 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?
- WGc-0201 injection and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2028
- 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
- Patients with pathologically confirmed hepatocellular carcinoma (HCC);
- Patients who have undergone curative resection or ablation (limited to radiofrequency ablation [RFA] or microwave ablation [MWA]) within 4-12 weeks prior to enrollment: For those who have undergone curative surgical resection, postoperative pathological examination must confirm negative surgical margins (R0 resection); for those who have undergone ablation, complete radiological response must be demonstrated (complete disappearance of arterial enhancement in all ablated tumor lesions);
- Patients with high-risk factors for recurrence and metastasis following curative resection of HCC;
- Positive for hepatitis B surface antigen (HBsAg);
- No extrahepatic metastasis confirmed by contrast-enhanced CT or MRI either before curative resection or postoperatively.
- (Additional inclusion criteria may be supplemented.)
Who cannot join
- Diagnosed with non-hepatocellular carcinoma such as fibrolamellar carcinoma, sarcomatoid carcinoma, or cholangiocarcinoma mixed with hepatocellular carcinoma;
- Evidence of residual tumor, recurrence, or metastasis;
- Clinically significant ascites;
- Received antitumor treatment after curative resection, excluding a single cycle of TACE (transarterial chemoembolization);
- History of hepatic encephalopathy. (Additional exclusion criteria may be supplemented.)
About this study
Official title: Phase I Clinical Study of HBx-based mRNA Vaccine (WGc-0201 Injection) Plus Tislelizumab in Hepahepatocellular Carcinoma With High Risk of Recurrence and Metastasis After Radical Therapy
urgical treatment represents a critical approach for HCC patients to achieve long-term survival, primarily including hepatectomy and liver transplantation. With the increasing implementation of HCC screening in China, the proportion of patients eligible for curative-intent surgical resection or ablation has risen annually. However, the 5-year tumor recurrence and metastasis rate post-surgery remains as high as 50%-70%. Postoperative adjuvant therapy has thus become essential to reduce the risk of recurrence and metastasis and improve patient survival. The target population for postoperative adjuvant therapy mainly comprises HCC patients who are suitable for surgical resection but exhibit high-risk factors for recurrence and metastasis. Currently, no internationally standardized adjuvant treatment regimen exists for patients with high postoperative recurrence and metastasis risks. While immunotherapy has demonstrated benefits for advanced HCC, its role in the adjuvant setting is still under exploration.
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. WGc-0201 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
- WGc-0201 injection, Tislelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGc-0201 injectionBiological
WGc-0201 injection
TislelizumabDrug
Tislelizumab, 200mg
| Study group | Role | What they receive |
|---|---|---|
| WGc-0201 injection, Dose 1 | Experimental | Not described Receives: Biological: WGc-0201 injection; Drug: Tislelizumab |
| WGc-0201 injection, Dose 2 | Experimental | Not described Receives: Biological: WGc-0201 injection; Drug: Tislelizumab |
| WGc-0201 injection, Dose 3 | Experimental | Not described Receives: Biological: WGc-0201 injection; Drug: Tislelizumab |
| WGc-0201 injection, Dose 4 | Experimental | Not described Receives: Biological: WGc-0201 injection; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: During one year after initial treatment
Secondary outcomes (3)
Recurrence-Free Survival (RFS)
Measured: During two years after initial treatment
Survival rate (2-year and 3-year)
Measured: During three years after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events
Measured: During two years 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 2027 (estimated)
- Study completion31 Dec 2028 (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
- 10 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
- NCT07077369
- Sponsor's protocol ID
- WGc-0201/Tislelizumab -HCC
- 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
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
- Phase I Clinical Study of HBx-based mRNA Vaccine (WGc-0201 Injection) Plus Tislelizumab in Hepahepatocellular Carcinoma With High Risk of Recurrence and Metastasis After Radical Therapy
- ClinicalTrials.gov ID
- NCT07077369
- Acronym / sponsor ID
- WGc-0201/Tislelizumab -HCC
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (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.
urgical treatment represents a critical approach for HCC patients to achieve long-term survival, primarily including hepatectomy and liver transplantation. With the increasing implementation of HCC screening in China, the proportion of patients eligible for curative-intent surgical resection or ablation has risen annually. However, the 5-year tumor recurrence and metastasis rate post-surgery remains as high as 50%-70%. Postoperative adjuvant therapy has thus become essential to reduce the risk of recurrence and metastasis and improve patient survival. The target population for postoperative adjuvant therapy mainly comprises HCC patients who are suitable for surgical resection but exhibit high-risk factors for recurrence and metastasis. Currently, no internationally standardized adjuvant treatment regimen exists for patients with high postoperative recurrence and metastasis risks. While immunotherapy has demonstrated benefits for advanced HCC, its role in the adjuvant setting is still under exploration.
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. WGc-0201 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 |
|---|---|---|
| WGc-0201 injection, Dose 1 | Experimental | Biological: WGc-0201 injection, Drug: Tislelizumab |
| WGc-0201 injection, Dose 2 | Experimental | Biological: WGc-0201 injection, Drug: Tislelizumab |
| WGc-0201 injection, Dose 3 | Experimental | Biological: WGc-0201 injection, Drug: Tislelizumab |
| WGc-0201 injection, Dose 4 | Experimental | Biological: WGc-0201 injection, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with pathologically confirmed hepatocellular carcinoma (HCC);
- Patients who have undergone curative resection or ablation (limited to radiofrequency ablation [RFA] or microwave ablation [MWA]) within 4-12 weeks prior to enrollment: For those who have undergone curative surgical resection, postoperative pathological examination must confirm negative surgical margins (R0 resection); for those who have undergone ablation, complete radiological response must be demonstrated (complete disappearance of arterial enhancement in all ablated tumor lesions);
- Patients with high-risk factors for recurrence and metastasis following curative resection of HCC;
- Positive for hepatitis B surface antigen (HBsAg);
- No extrahepatic metastasis confirmed by contrast-enhanced CT or MRI either before curative resection or postoperatively.
Key exclusion criteria (5 listed)
- Diagnosed with non-hepatocellular carcinoma such as fibrolamellar carcinoma, sarcomatoid carcinoma, or cholangiocarcinoma mixed with hepatocellular carcinoma;
- Evidence of residual tumor, recurrence, or metastasis;
- Clinically significant ascites;
- Received antitumor treatment after curative resection, excluding a single cycle of TACE (transarterial chemoembolization);
- History of hepatic encephalopathy. (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 |
|---|---|---|
| WGc-0201 injectionWGc-0201 injection | Biological | WGc-0201 injection, Dose 1, WGc-0201 injection, Dose 2, WGc-0201 injection, Dose 3, WGc-0201 injection, Dose 4 |
| TislelizumabTislelizumab, 200mg | Drug | WGc-0201 injection, Dose 1, WGc-0201 injection, Dose 2, WGc-0201 injection, Dose 3, WGc-0201 injection, Dose 4 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: During one year after initial treatment
3 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: During two years after initial treatment
Survival rate (2-year and 3-year)
Time frame: During three years after initial treatment
Safety: Type, frequency, and severity of treatment-related adverse events
Time frame: During two years 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WGc-0201 injection and Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by West China Hospital.
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 6 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: opening soon, 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: During one year after initial treatment). 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.