RecruitingPhase 1

PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.

China9 participantsStarted 2025-10-23

Plain-language summary

Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male or female patients: ≥18 years of age; ≤70 years of age;
✓. Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
✓. Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm);
✓. ECOG physical condition score: 0 to 1;
✓. Expected survival ≥ 3 months;
✓. Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
✓. Good compliance and family agreement to cooperate in receiving survival follow-up.

Exclusion criteria

✕. Participation in a clinical trial of another drug within 4 weeks;
✕. Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5 years prior to enrollment);
✕. Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or ventricular arrhythmias requiring treatment or intervention.
✕. For female subjects: women who are pregnant or breastfeeding.
✕. Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
✕. Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
✕. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to : uveitis, enteritis, pituitary gland inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has resolved completely in childhood and does not require any intervention in adulthood may be enrolled; subjects with asthma requiring medical intervention with bronchodilators may not be enrolled).
✕. Patients who have been inoculated with mRNA drugs.

What they're measuring

Adverse events

Timeframe: One month after the first vaccine dose

Trial details

NCT IDNCT07053072

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Xingchen Peng

18980606753 pxx2014@163.com

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