Actively Recruiting
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
Led by Yinghua Xu · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 consent
- Histologically or cytologically confirmed hepatocellular carcinoma eligible for radical surgery
- No tumor thrombus in portal vein, hepatic vein, or bile duct on pre-operative imaging
- No more than 3 tumor nodules and no spread outside the liver
- Clear and negative surgical margins after tumor removal
- High or intermediate risk of postoperative recurrence based on tumor features
- Ability to complete at least 4 cycles of standard postoperative adjuvant therapy
- Toxicities from previous anti-tumor treatments recovered to Grade 1 or less, excluding minor ones like alopecia or fatigue
- Expected survival time of at least 6 months
- ECOG performance status of 0 or 1
- Sufficient tumor tissue available for genetic analysis
- Left ventricular ejection fraction (LVEF) of at least 50%
- Blood tests meeting specified counts and biochemical parameters
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Male participants agreeing to use contraception
- Ability to comply with study protocol and follow-up
- Voluntary participation and signed informed consent
You will not qualify if you...
- History of other cancers requiring treatment within 5 years, except certain early-stage or non-serious cancers
- Major surgery or serious injury within 2 weeks before first treatment
- Unhealed wounds or fractures
- No eligible neoantigens found for personalized therapy
- History or planned bone marrow or organ transplantation
- Need for immunosuppressive therapy recently or ongoing use within 7 days before treatment
- Receipt or planned receipt of other vaccines near study period
- Active or uncontrolled severe infections including tuberculosis
- Positive tests for certain infections including hepatitis B or C, HIV, or syphilis
- History of autoimmune diseases requiring immunosuppressants or known immunodeficiency
- Significant heart or cerebrovascular disease or recent cardiac events
- Severe respiratory diseases or impaired lung function
- Significant fluid accumulation in abdomen or chest
- Substance abuse or psychological/social factors affecting participation
- History of hypersensitivity to immunotherapy or vaccines
- Investigator-assessed unsuitability for study or inability to complete it
- Vulnerable populations including mental illness, cognitive impairment, critically ill, pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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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
CONTACT
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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