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

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

Hepatocellular carcinoma (HCC) is the most common primary liver tumor. Surgical resection remains the first choice for early-stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized because the tumor recurrence rate is more than 50% in 5 years although the tumors are completely resected. In our large-scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease-free survival were 73.7%, 58.3% and 53.3%, respectively. Currently, there are no effective treatments used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DCs) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DCs pulsed with tumor-associated antigens can be used to conduct tumor-specific immunotherapy. Thereafter, DCs pulsed with HCC tumor antigens may be used as an adjuvant therapy to prevent HCC recurrence.

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.