RecruitingPhase 1Phase 2NCT06995105

Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy Combined With PD-1 Monoclonal Antibody and TACE for Advanced Hepatocellular Carcinoma

Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Summary

This study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody, anti-VEGFR monoclonal antibody and TACE regimen for the treatment of patients with advanced hepatocellular carcinoma.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine made from mRNA (similar technology to COVID-19 vaccines) that is custom-built using the unique genetic mutations of a patient's own liver tumor. This is being tested in people with advanced liver cancer (hepatocellular carcinoma) who have not yet received any treatment. **You may be eligible if...** - You are 18 to 75 years old with a confirmed liver cancer (hepatocellular carcinoma) diagnosis - Your cancer is at an advanced or unresectable stage but has not yet been treated with any systemic therapy - Your liver, kidneys, and heart are functioning adequately - There is a measurable tumor that can be biopsied for genetic analysis **You may NOT be eligible if...** - Your cancer has spread to the brain or the lining of the brain - You have another active cancer (other than certain cured skin or thyroid cancers) - You have HIV, active hepatitis B or C, or tuberculosis - You are pregnant or breastfeeding - You have a history of bone marrow transplant or organ transplant 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

PROCEDURETACE

The first day of TACE treatment is the first day (D1). TACE is started on D1. Subsequent TACE is arranged by the investigator based on a comprehensive assessment of the patient's physical condition, disease progression, adverse reactions, etc. The total number of TACEs shall not exceed 4 times, with at least 4 weeks between each two times.

DRUGSintilimab combined with Bevacizumab

Sintilimab (200 mg) combined with bevacizumab (Dayoutong injection, 15 mg/kg), intravenous infusion, once every 3 weeks, until the patient is intolerant or the tumor progresses

BIOLOGICALindividualized anti-tumor new antigen iNeo-Vac-R01 injection

The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.