A Phase 1 interventional study of Low Dose PD-1 mRNA LNP Vaccine and High dose PD-1 mRNA LNP vaccines in Liver Cancer, sponsored by West China Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by West China Hospital · Phase 1, Interventional, and Treatment
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
PD-1 mRNA LNP is an immune checkpoint mRNA vaccine loaded with the gene coding for the PD-1 protein Safety, tolerability, immunogenicity and preliminary efficacy of mRNA vaccines with PD-1 as the immunogen in the treatment of primary liver cancer. The aim of this study is to establish a novel PD-1-based mRNA for the treatment of advanced cancers.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 9 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
Exclusion Criteria:
Low-dose PD-1 mRNA LNP vaccine for advanced primary hepatocellular carcinoma failing standard therapy
Drug: Low Dose PD-1 mRNA LNP Vaccine
High Dose PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma Failing Standard Treatment
Drug: High dose PD-1 mRNA LNP vaccines
Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Also known as: PD-1 mRNA LNP vaccine at 50 mcg
Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Also known as: PD-1 mRNA LNP vaccine at 100 mcg
Adverse events
Adverse events defined as the number of participants with adverse events
Time frame: One month after the first vaccine dose
Disease Control Rate (DCR)
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overalresponse.
Time frame: Two month after the first vaccine dose
DRR (Durable Response Rate)
DRR is defined as the proportion of objective response (CR and PR as determined by the investigator) lasting at least 6 months at any time within 12 months of initiation of treatment.
Time frame: Six month after the first vaccine dose
DOR (Duration of Response)
DOR is defined as the time from the date when the PR is first recorded or better to the date when the disease progression is first recorded (for the responder, i.e., PR or better). Responders who did not record disease progress will be censored on the date that the last assessment was SD or better.
Time frame: Six month after the first vaccine dose
TTR (Response Time）
TTR is defined as the time from the date of the first administration to the date of the first record of the objective tumor response (CR and PR determined by the investigator).
Time frame: Six month after the first vaccine dose
PFS (progression-free survival)
PFS is defined as the duration until disease progression or death in participants fromthe first dose of immunization.
Time frame: Six month after the first vaccine dose
OS (Overall Survival)
0S is defined as the duration until death in participants from the first dose ofimmunization.
Time frame: Six month after the first vaccine dose
TTP (Time to Progression)
TTP is defined as the time from the date of first dose to the date of first documented disease progression, as defined by standard disease criteria.
Time frame: up to 6 months
Plan to share: No
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