Actively Recruiting
PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
Led by West China Hospital · Updated on 2026-04-23
9
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
CONDITIONS
Official Title
PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 70 years
- Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy
- At least one measurable target lesion according to RECIST criteria (CT scan lesion diameter ≥10 mm)
- ECOG physical condition score 0 to 1
- Expected survival of at least 3 months
- Good major organ function as shown by recent blood tests, liver function, kidney function, and heart ultrasound
- Willingness to comply with the study and agree to survival follow-up
You will not qualify if you...
- Participation in another drug clinical trial within the last 4 weeks
- History of other cancers unless treated and disease-free for at least 5 years (except certain skin or cervical cancers)
- Uncontrolled heart conditions including heart failure NYHA class 2 or higher, unstable angina, recent heart attack, or serious arrhythmias
- Pregnant or breastfeeding women
- Active tuberculosis, bacterial or fungal infections grade 2 or higher, HIV, active hepatitis B or C infections
- History of psychotropic substance abuse or mental disorders
- Active or past autoimmune diseases except fully resolved vitiligo or childhood asthma without current treatment
- Prior vaccination with mRNA drugs
- Participation in trials involving lipid nanoparticles
- Contraindications to intramuscular injection
- History of substance abuse or medical, psychological, or social conditions interfering with study
- Known allergy or intolerance to the vaccine or its components
- Planning pregnancy during screening and up to 12 months after treatment
- Any serious condition judged by the investigator to affect safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
2
Sichuan University West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xingchen Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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