Hepatocellular Carcinoma (HCC)Phase 1/2NCT07495215
A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection
A Phase 1/2 study testing iNeo-Vac-R01 in people with Hepatocellular Carcinoma (HCC), run by Yinghua Xu at 1 site in China.
Trial summary
iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- iNeo-Vac-R01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2025to 31 Dec 2028
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old (at the time of signing the informed consent form).
- Patients with histopathologically or cytologically confirmed hepatocellular carcinoma (HCC) eligible for radical resection; no tumor thrombus in the portal vein, hepatic vein or bile duct on pre-operative imaging; for multinodular patients, the number of tumor nodules ≤ 3 and no extrahepatic metastasis; clear margins of all tumor nodules and negative surgical margins after radical resection.
- High risk of postoperative recurrence, where high risk is defined as a single tumor lesion with microvascular invasion, or 2-3 tumor lesions; intermediate risk is defined as a single tumor lesion with a diameter > 5 cm and no microvascular invasion.
- Able to complete at least 4 cycles of the standard postoperative adjuvant therapy regimen in accordance with clinical guidelines; and toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, or to the levels specified in the inclusion/exclusion criteria (Note: Excluding Grade ≤ 2 toxicities such as alopecia, fatigue, or other toxicities assessed by the investigator as having no significant risk).
- Expected survival time of at least 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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- Sufficient tumor tissue samples can be obtained for genetic analysis: for puncture samples, at least 2 core biopsy tissues with tumor purity ≥ 50%; for surgical samples, a soybean-sized tissue sample.
- Echocardiography assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Hematological parameters meeting the following requirements:
- ① Routine blood test criteria
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L (no red blood cell transfusion within 7 days before the first administration of the mRNA injectable formulation)
- Platelet count ≥ 80 × 10⁹/L ② Biochemical parameter criteria
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- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
- Serum albumin ≥ 28 g/L
- Serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (per Cockcroft-Gault formula)
- Coagulation function criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (in patients not receiving anticoagulant therapy)
- For pregnant or lactating women: excluded; for women of childbearing potential, negative serum pregnancy test within 7 days before enrollment, no planned pregnancy in the short term, and willingness to adopt effective contraceptive measures (or other fertility control methods) before enrollment and during the study.
- Male patients are willing to adopt appropriate contraceptive methods.
- Able to comply with the study protocol and follow-up procedures.
- Voluntarily participate in the study and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., illiterate subjects), a witness shall observe the informed consent process and sign the form together with the subject.
Who cannot join
- A history of malignancy requiring anti-tumor therapy within 5 years prior to study enrollment (excluding treated Stage I prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, papillary thyroid cancer, and non-melanoma skin cancer).
- Major surgical treatment, significant traumatic injury within 2 weeks before the first personalized immunotherapy administration; or presence of unhealed wounds or fractures for a long time.
- No eligible neoantigens for personalized immunotherapy identified by sequencing data analysis.
- Planned or prior history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
- Requirement for immunosuppressant therapy, systemic or absorbable local hormonal therapy for immunosuppressive purposes, and continued use within 7 days before the first study drug administration (excluding systemic glucocorticoids at a daily dose < 10 mg prednisone equivalent).
- Receipt of any other vaccine within 4 weeks before study treatment initiation; or anticipated need for any other vaccine during the study treatment period or within 60 days after the last study treatment administration.
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- Presence of active or uncontrolled severe infection (including fungal, bacterial, viral or other infections); or active tuberculosis.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range; positive hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.
- A history of autoimmune disease or immunodeficiency with immunosuppressant therapy (excluding vitiligo, Type 1 diabetes mellitus, autoimmune hypothyroidism requiring hormonal therapy, and psoriasis not requiring systemic treatment); or a known history of primary immunodeficiency.
- Cardio-cerebrovascular events: a history or current diagnosis of Grade ≥ 3 cardiac valvular disease; or heart failure (New York Heart Association [NYHA] Class ≥ II), myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA) within 8 weeks before the first mRNA treatment administration; or cardiac-related surgery (including coronary artery bypass grafting [CABG], percutaneous coronary intervention [PCI]) within 8 weeks before the first drug administration; or severe electrocardiogram (ECG) abnormalities (e.g., ventricular flutter, ventricular fibrillation, polymorphic ventricular tachycardia, sick sinus syndrome, third-degree atrioventricular block without pacemaker therapy, QTc interval ≥ 480 ms, and other conditions assessed by the investigator as severely abnormal); or poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg); or other cardio-cerebrovascular diseases assessed by the investigator as unsuitable for study participation.
- Respiratory diseases: a history or current diagnosis of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, severe asthma, etc.; or patients with complicated pulmonary arterial hypertension or severe impairment of pulmonary function.
- Clinically significant moderate to severe ascites; uncontrolled or moderate to large pleural effusion or pericardial effusion.
- Substance abuse; or clinical, psychological or social factors that may affect the informed consent process or study implementation.
- A history of hypersensitivity to prior immunotherapeutic agents or vaccines; or other potential hypersensitivity to immunotherapy as assessed by the investigator.
- Assessed by the investigator as unsuitable for enrollment, or unable to complete the study for other reasons.
- Vulnerable populations, including patients with mental illness, cognitive impairment, critically ill patients, pregnant/lactating women, etc.
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
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
yinghua xu, +86 13666627003, xyh7003@163.com
About this study
Official title: A Clinical Study Evaluating the Safety, Tolerability and Efficacy of the Neoantigen-based Personalized mRNA Therapeutic Technology iNeo-Vac-R01 in Combination With a PD-1 Immune Checkpoint Inhibitor for Adjuvant Therapy After Radical Resection of Liver Cancer
iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells to eliminate tumor cells. This tumor therapeutic approach that harnesses the body's own immune system features high efficacy and low toxicity, with milder treatment responses and no severe adverse reactions for patients. This study aims to provide a novel personalized therapeutic strategy for the adjuvant treatment of post-operative liver cancer patients, with the research objectives of prolonging their disease-free survival (DFS) and overall survival (OS) following surgery.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- iNeo-Vac-R01
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNeo-Vac-R01Biological
iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a custom-made neoantigen mRNA injectable formulation produced by collecting patients' tumor tissues and peripheral blood, screening eligible neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells, thereby eliminating tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | Not described Receives: Biological: iNeo-Vac-R01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability dose
According to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicities will be counted as an indicator to evaluate the safety and tolerability of iNeo-Vac-R01 Injection. The safety data visit window will be 21 days after the last treatment.
Measured: 210 days
Secondary outcomes (1)
Primary efficacy endpoints，include disease-free survival (DFS) and overall survival (OS)
- Relapse-free survival (RFS): Time from the date of the first administration of iNeo-Vac-R01 Injection to the date of disease relapse or death from any cause, with an assessment period of 3 years.
- Overall survival (OS): Time from the date of the first administration of iNeo-Vac-R01 Injection to death from any cause, with an assessment period of 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start11 Sep 2025
- Primary completion31 Dec 2028 (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.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yinghua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yinghua Xu, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495215
- Sponsor's protocol ID
- 2025-2715-01
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety, Tolerability and Efficacy of the Neoantigen-based Personalized mRNA Therapeutic Technology iNeo-Vac-R01 in Combination With a PD-1 Immune Checkpoint Inhibitor for Adjuvant Therapy After Radical Resection of Liver Cancer
- ClinicalTrials.gov ID
- NCT07495215
- Acronym / sponsor ID
- 2025-2715-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yinghua XuUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 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.
iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells to eliminate tumor cells. This tumor therapeutic approach that harnesses the body's own immune system features high efficacy and low toxicity, with milder treatment responses and no severe adverse reactions for patients. This study aims to provide a novel personalized therapeutic strategy for the adjuvant treatment of post-operative liver cancer patients, with the research objectives of prolonging their disease-free survival (DFS) and overall survival (OS) following surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Biological: iNeo-Vac-R01 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Aged 18 to 75 years old (at the time of signing the informed consent form).
- Patients with histopathologically or cytologically confirmed hepatocellular carcinoma (HCC) eligible for radical resection; no tumor thrombus in the portal vein, hepatic vein or bile duct on pre-operative imaging; for multinodular patients, the number of tumor nodules ≤ 3 and no extrahepatic metastasis; clear margins of all tumor nodules and negative surgical margins after radical resection.
- High risk of postoperative recurrence, where high risk is defined as a single tumor lesion with microvascular invasion, or 2-3 tumor lesions; intermediate risk is defined as a single tumor lesion with a diameter > 5 cm and no microvascular invasion.
- Able to complete at least 4 cycles of the standard postoperative adjuvant therapy regimen in accordance with clinical guidelines; and toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, or to the levels specified in the inclusion/exclusion criteria (Note: Excluding Grade ≤ 2 toxicities such as alopecia, fatigue, or other toxicities assessed by the investigator as having no significant risk).
- Expected survival time of at least 6 months.
Key exclusion criteria (16 listed)
- A history of malignancy requiring anti-tumor therapy within 5 years prior to study enrollment (excluding treated Stage I prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, papillary thyroid cancer, and non-melanoma skin cancer).
- Major surgical treatment, significant traumatic injury within 2 weeks before the first personalized immunotherapy administration; or presence of unhealed wounds or fractures for a long time.
- No eligible neoantigens for personalized immunotherapy identified by sequencing data analysis.
- Planned or prior history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
- Requirement for immunosuppressant therapy, systemic or absorbable local hormonal therapy for immunosuppressive purposes, and continued use within 7 days before the first study drug administration (excluding systemic glucocorticoids at a daily dose < 10 mg prednisone equivalent).
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 |
|---|---|---|
| iNeo-Vac-R01iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a custom-made neoantigen mRNA injectable formulation produced by collecting patients' tumor tissues and peripheral blood, screening eligible neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells, thereby eliminating tumor cells. | Biological | Participant Group |
Primary outcome
safety and tolerability dose
Time frame: 210 days
According to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicities will be counted as an indicator to evaluate the safety and tolerability of iNeo-Vac-R01 Injection. The safety data visit window will be 21 days after the last treatment.
1 secondary outcome
Primary efficacy endpoints，include disease-free survival (DFS) and overall survival (OS)
Time frame: 3 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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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 1/2 study testing iNeo-Vac-R01 in people with Hepatocellular Carcinoma (HCC), run by Yinghua Xu 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 23 inclusion and 16 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 27 Mar 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yinghua Xu (+86 13666627003, xyh7003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability dose (time frame: 210 days). 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 27 Mar 2026.