Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma

ConditionAdvanced Hepatocellular Carcinoma (HCC)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhejiang University

About this trial

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 criteria

Qualifiers

Voluntarily sign the informed consent form;

Aged ≥18 years and ≤75 years, regardless of gender;

Strictly meet the 2018 American Association for Clinical Diagnosis of Liver Diseases (AASLD) clinical diagnostic criteria for HCC, and imaging assessment is unresectable/metastatic hepatocellular carcinoma (HCC), CNLC stage Ib to IIIb;

Have not received systemic or local treatment for HCC in the past.

Disqualifiers

1) Diffuse HCC. 2) Known fibrolamellar HCC, cholangiocarcinoma, and mixed HCC. 3) Concomitant tumor thrombus in the main portal vein or contralateral portal vein, superior mesenteric vein, or vena cava.

Trial design

Treatments tested in this trial

TACE
Sintilimab combined with Bevacizumab
individualized anti-tumor new antigen iNeo-Vac-R01 injection

Treatment groups

30 Participants

are divided into 1 treatment group

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator

Source ClinicalTrials.gov