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A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection

NCT07495215 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-27

No results posted yet for this study

Summary

iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells to eliminate tumor cells. This tumor therapeutic approach that harnesses the body's own immune system features high efficacy and low toxicity, with milder treatment responses and no severe adverse reactions for patients. This study aims to provide a novel personalized therapeutic strategy for the adjuvant treatment of post-operative liver cancer patients, with the research objectives of prolonging their disease-free survival (DFS) and overall survival (OS) following surgery.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

BIOLOGICAL

iNeo-Vac-R01

iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a custom-made neoantigen mRNA injectable formulation produced by collecting patients' tumor tissues and peripheral blood, screening eligible neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells, thereby eliminating tumor cells.

Sponsors & Collaborators

  • Yinghua Xu

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07495215 on ClinicalTrials.gov