Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial

Inclusion criteria

• The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are $\\ge 101$ [Hepatitis, score 57; platelet $< 100\\times10^3$, score 72; multiple tumors, score 69; cirrhosis, score 62; microvascular invasion, score 100; total tumor volume $> 43.3\\text{cm}^3$, score 90].
• Age ≧20 years old and sign informed consent.
• BCLC stage A-C
• Child-Pugh sore ≤ 6
• Percentage of lymphocytes in peripheral blood ≧12%.
• Performance status ECOG ≦2
• AST and ALT ≦ 5x upper limit of normal.
• Platelet ≥ 80000/mm3
• WBC ≥ 3000/uL
• RBC ≥ 2.5x106/uL
• eGFR ≥ 30ml/min/1.73m2
• The patients must be disease-free after liver resection, which is confirmed by dynamic CT or MRI within 14 days.
• The participants must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
• The participants must agree to harvest and preserve tumor specimens during operation.

Exclusion criteria

• Subjected having other malignancies except HCC are excluded.
• Uncontrolled or clinically significant cardiac diseases.
• Positive for HIV.
• Active bacterial of fungal infections.
• Prior chemotherapy within one month.
• Use of other investigational drugs within one month.
• Subjects with systemic steroid treatment within 14 days.
• Subjects in the status of immune deficiency.
• Subjects in the status of autoimmune diseases.
• Subjects with long-term use of immunosuppressive agents.
• Subjects with checkpoint inhibitor immunotherapy within one month.
• Subjects with local regional therapy within one month.