Actively Recruiting
Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2025-05-29
30
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody, anti-VEGFR monoclonal antibody and TACE regimen for the treatment of patients with advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Aged 18 to 75 years, any gender
- Meet the 2018 AASLD clinical diagnostic criteria for hepatocellular carcinoma (HCC) with unresectable or metastatic disease, CNLC stage Ib to IIIb
- No prior systemic or local treatment for HCC
- Presence of measurable tumors according to RECIST 1.1 criteria
- Child-Pugh score of 7 points or less
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to provide adequate fresh tumor tissue for genetic sequencing
- Normal heart, liver, and kidney functions with specific laboratory values within defined limits
- Male patients with fertility and females of childbearing potential agree to use effective contraception from consent signing to 6 months after last treatment
- Able to comply with study protocol and follow-up requirements
- Primary HCC confirmed by pathology before treatment
You will not qualify if you...
- Diffuse HCC, fibrolamellar HCC, cholangiocarcinoma, or mixed HCC
- Tumor thrombus in major veins such as the main portal vein, contralateral portal vein, superior mesenteric vein, or vena cava
- History of meningeal disease or presence of central nervous system metastases
- History or evidence of pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonia, or active pneumonia on screening
- Presence of other active malignant tumors except certain cured cancers with low relapse risk
- History of bone marrow, organ, or hematopoietic stem cell transplantation
- Use of immunosuppressants regularly 4 weeks before screening and during the study, except certain mild autoimmune diseases
- Active bacterial, fungal, or tuberculosis infections
- Positive tests for HIV, Treponema pallidum, active hepatitis B or C
- Recent herpes or respiratory viral infections
- Uncontrolled medical conditions including infections, severe heart or cerebrovascular diseases
- History of drug abuse, mental illness, or factors affecting consent or study compliance
- History of allergies to drugs, vaccines, or immunotherapy
- Pregnant or breastfeeding women
- Any other conditions judged by investigators to make participation unsuitable or incomplete
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
T
Tingbo Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here