Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma

Sponsor
Zhejiang University
Study ID
NCT06995105
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TACE — PROCEDURE
    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.
  • Sintilimab combined with Bevacizumab — DRUG
    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
  • individualized anti-tumor new antigen iNeo-Vac-R01 injection — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
May 29, 2025
Start date
Apr 9, 2025
Status verified
May 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group (mRNA therapy+PD-1+anti-VEGFR+TACE)
    1. After pathological diagnosis, the patient will pass the screening of the inclusion group and enter the study medication process; 2. During the screening period, the patient can start TACE treatment first, and the subsequent treatment will be arranged by the researcher based on the patient's physical condition, disease progression, etc. The total number shall ≤ 4 times, and the interval between each two times shall be at least 4 weeks; 3. After the patient enters the study medication process, he/she needs to first use 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; the first use of sintilimab and Dayutong injection is the first day (D1) 4. D43±3 (week 7±3 days), the first efficacy evaluation, if the patient has no disease progression, he/she will receive treatment (sintilimab Q3W + bevacizumab Q3W + the first batch of personalized mRNA inject Q3W)

Primary Outcome Measure

Adverse events [ Time Frame: The evaluation period was the dosing observation period and the safety follow-up period (21±3 days after the last dose). ]

Central Contacts