Actively Recruiting
Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy Combined With PD-1 Monoclonal Antibody and TACE for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2025-05-29
30
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and feasibility of a personalized tumor neoantigen mRNA therapy called iNeo-Vac-R01 in combination with PD-1 monoclonal antibody, anti-VEGFR monoclonal antibody, and transarterial chemoembolization (TACE) for patients with advanced hepatocellular carcinoma (HCC). This clinical trial is designed for adults aged 18 to 75 years with unresectable or metastatic HCC, aiming to study new treatment options in advanced liver cancer. Participants will first undergo pathological diagnosis and screening, which includes starting TACE treatment up to four times with at least four weeks between procedures. Following this, patients receive intravenous infusions of sintilimab (200 mg) combined with bevacizumab (15 mg/kg) every three weeks until intolerance or tumor progression occurs. Around week 7, if no disease progression is detected, patients will also receive personalized mRNA injections every three weeks along with continued infusions of sintilimab and bevacizumab. During the study, participants will be monitored for adverse events during dosing and follow-up periods, with safety evaluations conducted up to 21 days after the last dose. Researchers will assess objective response rate, disease control rate, conversion rate, progression-free survival, and overall survival for up to two to three years. Patients will undergo regular assessments including imaging to evaluate tumor response and will be followed for long-term outcomes and safety through the study period ending in 2028.
CONDITIONS
Brief 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 2018 AASLD clinical diagnostic criteria for hepatocellular carcinoma (HCC), unresectable/metastatic, CNLC stage Ib to IIIb
- No prior systemic or local treatment for HCC
- Presence of measurable lesions by RECIST 1.1 criteria
- Child-Pugh score of 7 points or less
- ECOG performance status of 0 or 1
- Adequate fresh tumor tissue available for sequencing analysis
- Normal heart, liver, and kidney functions as defined by specific laboratory values
- Male patients with fertility and females of childbearing age agree to use effective contraception during and 6 months after treatment
- Able to follow study protocol and attend follow-up visits
You will not qualify if you...
- Diffuse HCC, fibrolamellar HCC, cholangiocarcinoma, or mixed HCC
- Tumor thrombus in main portal vein, contralateral portal vein, superior mesenteric vein, or vena cava
- History of meningeal disease or central nervous system metastases
- History or evidence of pulmonary fibrosis, pneumonia, or active pneumonia
- Concurrent malignant tumors except certain cured types with low relapse risk
- History of bone marrow, organ, or stem cell transplantation
- Regular use of immunosuppressants or severe immune-related conditions
- Active bacterial, fungal, tuberculosis, HIV, hepatitis B or C infections
- Recent herpes or respiratory virus infections
- Uncontrolled infections or severe cardiovascular or cerebrovascular diseases
- History of drug abuse or mental illness affecting consent
- History of allergies to drugs, vaccines, or immunotherapies
- Pregnant or breastfeeding women
- Any condition that investigators consider unsuitable for study participation or completion
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.
1 screening and enrollment visit
Duration - Variable; TACE up to 4 times with ≥4 weeks interval, drug infusions and mRNA injections continue until intolerance or tumor progression
Participants receive TACE procedures up to 4 times with at least 4 weeks between each. They also receive intravenous infusions of sintilimab and bevacizumab every 3 weeks until intolerance or tumor progression. Personalized mRNA therapy injections start around week 7 if there is no disease progression and are given every 3 weeks alongside sintilimab and bevacizumab.
Multiple visits every 3 weeks for drug infusions and mRNA injections; up to 4 TACE procedures spaced by at least 4 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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