Actively Recruiting
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
Led by Yinghua Xu · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating iNeo-Vac-R01, a personalized neoantigen-based mRNA therapy designed for patients with liver cancer (hepatocellular carcinoma) who have undergone surgery to remove tumors. This therapy aims to stimulate the patient's own immune system by using customized mRNA formulations developed from their tumor tissue and blood samples. The study focuses on assessing the safety, tolerability, and effectiveness of this approach combined with a PD-1 immune checkpoint inhibitor to improve disease-free survival and overall survival after surgery. The treatment involves creating a personalized mRNA injectable formulation by identifying suitable neoantigens through high-throughput sequencing of tumor samples and encapsulating them in liposomes to boost patient-specific T cell activity. Participants will receive this experimental therapy alongside a PD-1 inhibitor as an adjuvant treatment following radical resection of liver cancer. The study is conducted in Phases 1 and 2 to evaluate safety over 210 days and to monitor efficacy outcomes up to three years. Participants will be closely monitored throughout the study with regular assessments including safety and tolerability checks, clinical evaluations, and follow-up visits to track disease recurrence and survival. Researchers will measure primary endpoints related to safety and secondary endpoints focusing on disease-free and overall survival. The study duration allows for long-term observation to understand the therapy's impact and any adverse effects, ensuring comprehensive data collection for this personalized cancer treatment approach.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old at the time of informed consent
- Histopathologically or cytologically confirmed hepatocellular carcinoma eligible for radical resection
- No tumor thrombus in portal vein, hepatic vein, or bile duct on pre-operative imaging
- For multinodular patients, tumor nodules 63 and no extrahepatic metastasis
- Clear margins of all tumor nodules and negative surgical margins after resection
- High risk of postoperative recurrence defined by microvascular invasion or tumor lesion criteria
- Able to complete at least 4 cycles of standard postoperative adjuvant therapy
- Toxicities from prior therapy recovered to 61 Grade 1 per NCI-CTCAE v5.0 (excluding some low-risk toxicities)
- Expected survival time of at least 6 months
- ECOG performance status score of 0 or 1
- Sufficient tumor tissue available for genetic analysis
- Left ventricular ejection fraction (LVEF) 650%
- Hematological and biochemical parameters within specified limits
- Negative pregnancy test for women of childbearing potential and willingness to use contraception
- Male patients willing to use appropriate contraceptive methods
- Able to comply with study protocol and follow-up
- Voluntary participation and signed informed consent
You will not qualify if you...
- History of malignancy requiring anti-tumor therapy within 5 years (except certain early-stage cancers)
- Major surgery or significant injury within 2 weeks before first treatment
- No eligible neoantigens found for personalized immunotherapy
- Planned or prior bone marrow or organ transplantation
- Need for immunosuppressant therapy or systemic hormonal therapy within 7 days before treatment
- Receipt or planned receipt of any other vaccine within specified timeframes
- Active or uncontrolled severe infections, including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active viral load
- History of autoimmune disease or immunodeficiency with immunosuppressant therapy (with some exceptions)
- Significant cardio-cerebrovascular disease or poorly controlled hypertension
- Severe respiratory diseases or impaired pulmonary function
- Moderate to severe ascites or uncontrolled pleural/pericardial effusion
- Substance abuse or factors affecting consent or study participation
- History of hypersensitivity to immunotherapy agents or vaccines
- Investigator assessment of unsuitability for enrollment or inability to complete study
- Vulnerable populations such as mental illness, cognitive impairment, critically ill patients, pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 210 days
Participants receive personalized neoantigen-based mRNA therapy iNeo-Vac-R01 combined with a PD-1 immune checkpoint inhibitor as adjuvant therapy after radical resection of liver cancer.
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
Y
Yinghua Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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