Application of mRNA Vaccine in Liver Transplantation for Hepatocellular Carcinoma

Launched by WEST CHINA HOSPITAL · Jul 13, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new type of vaccine called an mRNA therapeutic vaccine to help people with liver cancer (specifically hepatocellular carcinoma or HCC) who need a liver transplant. Liver cancer linked to hepatitis B virus (HBV) is common, especially in certain parts of the world, and even after a liver transplant, the cancer often comes back. This vaccine aims to train the body’s immune system to better fight the cancer by targeting specific parts related to HBV. It’s a new approach that has shown promise in early lab studies for being safe and potentially effective.

Adults with liver cancer caused by hepatitis B who are planning to have a liver transplant may be able to join the study. To qualify, participants need to be in generally good health aside from their cancer and meet certain medical criteria, such as testing positive for hepatitis B surface antigen (a marker of infection). The trial is currently looking for volunteers and will provide this vaccine as a treatment during the waiting period before transplant. Participants can expect close medical monitoring to see how well the vaccine works and to check for any side effects. This study is important because it explores a new way to help prevent cancer from coming back after a transplant, offering hope for better long-term outcomes.

Gender

ALL

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.)