Study of Personalized Neoantigen mRNA Therapy iNeo-Vac-R01 with PD-1 Inhibitor as Adjuvant Treatment After Liver Cancer Surgery

What this Trial Is About

Researchers are evaluating iNeo-Vac-R01, a personalized neoantigen-based mRNA therapy designed for patients with liver cancer hepatocellular carcinoma who have undergone surgery to remove tumors. This therapy aims to stimulate the patients own immune system by using customized mRNA formulations developed from their tumor tissue and blood samples. The study focuses on assessing the safety, tolerability, and effectiveness of this approach combined with a PD-1 immune checkpoint inhibitor to improve disease-free survival and overall survival after surgery. The treatment involves creating a personalized mRNA injectable formulation by identifying suitable neoantigens through high-throughput sequencing of tumor samples and encapsulating them in liposomes to boost patient-specific T cell activity. Participants will receive this experimental therapy alongside a PD-1 inhibitor as an adjuvant treatment following radical resection of liver cancer. The study is conducted in Phases 1 and 2 to evaluate safety over 210 days and to monitor efficacy outcomes up to three years. Participants will be closely monitored throughout the study with regular assessments including safety and tolerability checks, clinical evaluations, and follow-up visits to track disease recurrence and survival. Researchers will measure primary endpoints related to safety and secondary endpoints focusing on disease-free and overall survival. The study duration allows for long-term observation to understand the therapys impact and any adverse effects, ensuring comprehensive data collection for this personalized cancer treatment approach.

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