Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • TACE

    Procedure/Surgery

    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/Vaccine

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental group (mRNA therapy+PD-1+anti-VEGFR+TACE)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events

According to the Commonly Used Adverse Event Criteria (CTCAE version 5.0), the number of subjects with adverse events and/or dose-limiting toxicity was counted as an indicator of the safety and tolerable dose of iNeo-Vac-R01 injection.

Time frame
The evaluation period was the dosing observation period and the safety follow-up period (21±3 days after the last dose).

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Up to 2 years
2

Disease control rate (DCR)

Time frame
Up to 2 years
3

Conversion rate

the proportion of patients with initially inoperable tumors who are successfully converted to patients who can undergo radical surgical resection after systemic treatment in conversion therapy

Time frame
Up to 2 years
4

Progression-free survival （PFS）

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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