HBV mRNA vaccine to lower HCC recurrence around liver transplant

Application of mRNA Vaccine in Liver Transplantation for Hepatocellular Carcinoma

This trial will test whether an HBV-targeted mRNA vaccine can reduce hepatocellular carcinoma recurrence in adults with hepatitis B who are awaiting or undergoing liver transplantation.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Chengdu)
• Trial ID: NCT07077356 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional trial of an HBV mRNA vaccine given to adults with hepatitis B–related hepatocellular carcinoma who are eligible for liver transplantation and may need bridge or downstaging therapy while on the transplant waitlist. The primary focus is early safety, tolerability, and immune response signals of the vaccine in the transplant setting, with secondary attention to effects on tumor control during the waiting period. Participants will receive the investigational vaccine at West China Hospital (Sichuan University) and undergo scheduled clinical and laboratory follow-up. The intent is to establish a safe dose and preliminary evidence to guide later efficacy trials.

Who should consider this trial

Good fit: Adults (≥18) with confirmed hepatocellular carcinoma who are HBsAg positive, deemed eligible for liver transplantation and needing bridge or downstaging therapy, and with ECOG performance status 0–2 are the intended candidates.

Not a fit: Patients who are HBsAg negative, not transplant candidates, have uncontrolled comorbidities or certain recent other cancers are unlikely to benefit from this investigational vaccine.

Why it matters

Potential benefit: If successful, the vaccine could lower the chance of HCC coming back after transplant and help control hepatitis B infection.

How similar studies have performed: mRNA cancer vaccines have shown early promise in other tumor types, but use of an HBV-targeted mRNA vaccine in the liver transplant setting is novel and has limited prior data.

Eligibility criteria

Inclusion Criteria:

* 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;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2; (Additional inclusion criteria may be supplemented.)

Exclusion Criteria:

* History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;
* 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;
* Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin); (Additional exclusion criteria may be supplemented.)

Where this trial is running

Chengdu

• West China Hospital, Sichuan University — Chengdu, China (RECRUITING)

Conditions: Hepatocellular Carcinoma, Liver Transplantation