Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2028

Conditions
Advanced Hepatocellular Carcinoma (HCC)
Interventions
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.

Trial Locations (1)

310003

RECRUITING

the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

Hangzhou Neoantigen Therapeutics Co., Ltd.

INDUSTRY

lead

Zhejiang University

OTHER