Application of mRNA Vaccine in Liver Transplantation for Hepatocellular Carcinoma

NCT07077356 | Recruiting Phase 1

• 1 other identifier: HBV mRNA-Liver Tx
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The therapeutic options for HCC include hepatectomy, liver transplantation, local ablation therapy, transarterial chemoembolization (TACE), radiotherapy, and systemic therapy. However, as early-stage HCC often presents with no obvious symptoms or atypical clinical manifestations, over 80% of patients are diagnosed at an advanced stage, losing the opportunity for surgical resection and leaving liver transplantation as the only potentially curative option. Nevertheless, even after liver transplantation, the recurrence rate of HCC remains as high as 30-45%. In recent years, with the successive launch of novel targeted drugs and immune checkpoint inhibitors, Chinese patients with HCC have gained more treatment options for both disease management and recurrence prevention. However, given the heterogeneity of HCC, only a subset of patients benefit from these therapies. Hepatitis B virus (HBV) infection is the primary risk factor for HCC, accounting for at least 50% of global HCC cases. In regions with high HBV prevalence-such as East and Southeast Asia, as well as sub-Saharan Africa-the proportion is even higher. While HBV-related HCC can be prevented through vaccination against HBV infection, no specific precision therapy currently exists for patients already diagnosed with HBV-positive HCC. Given that nucleic acid vaccine technology demonstrates value not only in disease prevention but also in immunotherapy-particularly mRNA therapeutic vaccines-this approach holds promise. mRNA therapeutic vaccines represent a highly promising new modality for tumor treatment. They offer advantages such as excellent safety, long-term expression, and sustained antigen presentation. Additionally, they can mimic the natural infection process of viruses to activate the immune system, eliciting robust immune responses against tumors. Currently, no mRNA therapeutic vaccines targeting HBV-related antigens have been approved for marketing. This HBV mRNA injection is an mRNA therapeutic vaccine encoding HBV-related specific antigens. Its active ingredient consists of modified mRNA encoding HBV-related antigen proteins, formulated into an injectable preparation via lipid nanoparticle (LNP) encapsulation. Preclinical safety evaluations have demonstrated that this vaccine exhibits low toxicity and good tolerability. Building on these preliminary results, this study aims to further evaluate its potential.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma; Liver Transplantation

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLTs) and their incidence rates

  During one year after initial treatment

• Safety: Type, frequency, and severity of treatment-related adverse events as assessed by CTCAE V5.0

  During one year after initial treatment

Secondary Outcomes (4)

• Objective response rate (ORR)

  During one year after initial treatment

• Disease control rate (DCR)

  During one year after initial treatment

• 1-year survival rate

  During one year after initial treatment

• Immunogenicity: The level of antigen-specific T cells

  During one year after initial treatment

Study Arms (4)

HBV mRNA vaccine, Dose 1

EXPERIMENTAL

Biological: HBV mRNA vaccine

HBV mRNA vaccine, Dose 2

EXPERIMENTAL

Biological: HBV mRNA vaccine

HBV mRNA vaccine, Dose 3

EXPERIMENTAL

Biological: HBV mRNA vaccine

HBV mRNA vaccine, Dose 4

EXPERIMENTAL

Biological: HBV mRNA vaccine

Interventions

HBV mRNA vaccine BIOLOGICAL

HBV mRNA vaccine

HBV mRNA vaccine, Dose 1; HBV mRNA vaccine, Dose 2; HBV mRNA vaccine, Dose 3; HBV mRNA vaccine, Dose 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥18 years;
• Patients with histologically, cytologically, or clinically diagnosed hepatocellular carcinoma (HCC);
• Patients who, based on the investigator's assessment, meet the indications for liver transplantation and have expressed willingness to undergo transplantation, with a need for bridge therapy or downstaging therapy during the transplant waiting period as evaluated by the investigator;
• Positive for hepatitis B surface antigen (HBsAg) in peripheral blood;

You may not qualify if:

• History of or current hepatic encephalopathy; known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;
• Clinically significant ascites requiring therapeutic intervention at present;
• Known clinically significant uncontrolled cardiac symptoms or diseases;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Tumor Biological Therapy, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (1)