Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT07053072

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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