RecruitingPhase 1NCT07053072

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


Sponsor

West China Hospital

Enrollment

9 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental mRNA vaccine delivered in tiny fat particles (lipid nanoparticles) that blocks a protein called PD-1, which cancer cells use to hide from the immune system. It is being tested in people with advanced liver cancer (hepatocellular carcinoma) that has not responded to other treatments. **You may be eligible if...** - You have been diagnosed with advanced primary liver cancer (hepatocellular carcinoma) - Your cancer has not responded to, or you cannot tolerate, standard treatments - Your liver function and general health meet minimum requirements - You have at least one measurable tumor **You may NOT be eligible if...** - You have liver cancer caused by another primary cancer that spread to the liver - You have severe liver disease or cirrhosis that significantly impairs liver function - You have an active autoimmune disease - You have a serious infection or are immunocompromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose PD-1 mRNA LNP Vaccine

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.

DRUGHigh dose PD-1 mRNA LNP vaccines

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.


Locations(2)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sichuan University West China Hospital

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT07053072


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