Loading clinical trials...

PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma. | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy

NCT07053072•West China Hospital

View on ClinicalTrials.gov

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

Detailed Description

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients: ≥18 years of age; ≤70 years of age;
•2. Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
•3. 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);
•4. ECOG physical condition score: 0 to 1;
•5. Expected survival ≥ 3 months;
•6. Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
•* Routine blood tests: hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count \>1.5×109 /L; platelet count ≥80×109 /L;
•* Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
•* cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.
•7. Good compliance and family agreement to cooperate in receiving survival follow-up.

Exclusion Criteria

•1. Participation in a clinical trial of another drug within 4 weeks;
•2. 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);
•3. 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.
•4. For female subjects: women who are pregnant or breastfeeding.
•5. Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
•6. Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
•7. 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).
•8. Patients who have been inoculated with mRNA drugs.
•9. Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine.
•10. Contraindications to intramuscular injection.
+4 more criteria

Locations (2)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sichuan University West China Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

October 23, 2025

Primary Completion Date

September 30, 2026

Completion Date

December 30, 2026

Last Updated

December 10, 2025

Enrollment

ESTIMATED participants

Conditions

Liver Cancer

Interventions

Low Dose PD-1 mRNA LNP Vaccine

DRUG

Medium dose PD-1 mRNA LNP vaccines

DRUG

High dose PD-1 mRNA LNP vaccines

DRUG

Contacts

Xingchen Peng

CONTACT

18980606753 pxx2014@163.com

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

View study

RECRUITINGPHASE2

Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

NCT07447050

Breast CancerSarcoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Early Detection of Liver Cancer by QUS

Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

Cancer Loyalty Card Study 2 (CLOCS-2)

vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC

Diagnostic Accuracy of Folate-Targeted NIR-II Carbon Dots for Ex Vivo HCC Detection