Phase Ⅰ clinical study of combination therapy with microwave ablation and cellular immunotherapy in hepatocellular carcinoma

BACKGROUND AND AIMS: To observe safety and influence on viral load and peripheral T lymphocyte subsets of combination therapy with percutaneous microwave ablation (PMWA) and adoptive immunotherapy in hepatocellular carcinoma (HCC) with hepatitis B. RESULTS: No adverse effects of grade Ⅲ/Ⅳ were observed. Viral load was decreased in 57.14% (four of seven) of patients and was undetectable in two (28.6%) patients without antiviral therapy. The percentage of CD4(+)CD25(high) regulatory T lymphocytes decreased significantly, and the percentage of CD8(+)CD28(-) effector cells increased significantly 1 month after therapy. However, 6 months after therapy, there was no significant difference. METHODS: Ten HCC (D≤5 cm, fewer than 3 tumors) patients were treated with radical PMWA and three courses of immunotherapy, which were started with PMWA, 2 weeks post-PMWA, and 3 months after PMWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. Immature DCs, cytokine-induced killer cells (CIK) and cytotoxic T lymphocytes (CTL) were injected into the marginal area of ablated tumors under contrast-enhanced sonographic guidance. Under sonographic guidance, tumor lysate-pulsed DC was injected into groin lymph nodes, while DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously. CONCLUSION: Adoptive immunotherapy prescribed soon after PMWA for HCC patients was safe and ameliorated the percentage of peripheral lymphocytes.