HBV mRNA vaccine to lower HCC recurrence around liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital, Sichuan University
  Chengdu, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PULSAR radiotherapy plus immunotherapy for high-risk advanced liver cancer

  This study tests whether adding PULSAR radiotherapy to standard immunotherapy helps adults with high‑risk advanced liver cancer live longer without their cancer progressing.

  Recruiting Phase 2 Samsung Medical Center · Seoul · NCT07884877

• AI-guided treatment choices for advanced liver cancer

  Researchers are testing an AI tool to help predict which patients with advanced hepatocellular carcinoma will respond to modern systemic therapies.

  Recruiting at 5 sites Universitaire Ziekenhuizen KU Leuven · Anderlecht and 4 other locations · NCT07863258

• Intratumoral oncolytic virus plus immune checkpoint inhibitors in metastatic colorectal, gastric, or liver cancer

  Doctors are testing whether injecting an oncolytic virus directly into tumors along with immune checkpoint drugs is safe and may help people with advanced colorectal, gastric, or liver cancer who have tried many treatments.

  Recruiting Foshan Fosun Chancheng Hospital · Guangdong, Foshan · NCT07850882

• Biomarker testing to predict treatment response and recurrence in liver cancer

  This study tests biomarkers in adults with hepatocellular carcinoma to see if they can predict how well treatments work and the chance of the cancer coming back.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin · NCT07840092

• MRI plus diffusion and CEST imaging to map liver cancer and its immune environment

  This study tests whether adding an extra MRI sequence can help see how the liver cancer microenvironment changes and relate those changes to immune activity in patients with hepatocellular carcinoma.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07838415

• Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

  This study tests whether adding irreversible electroporation to lenvatinib and sintilimab can help patients with unresectable advanced hepatocellular carcinoma see bigger tumor shrinkage and become eligible for surgery.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China · NCT07832006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.