NCT06995105

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
PROCEDURE	TACE	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.
DRUG	Sintilimab 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
BIOLOGICAL	individualized 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.

Timeline

• Start date: 2025-04-09
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: China