NCT07495215

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

A Clinical Study Evaluating the Safety, Tolerability and Efficacy of the Neoantigen-based Personalized mRNA Therapeutic Technology iNeo-Vac-R01 in Combination With a PD-1 Immune Checkpoint Inhibitor for Adjuvant Therapy After Radical Resection of Liver Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yinghua Xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-09-11
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China