Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).

Detailed Description
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HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year. The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously. The safety, survival effect and peripheral T-lymphocyte subsets of combination therapy group will be recorded and compared with those of MWA group.

Official Title
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Combination Therapy of Microwave Ablation and Expanding Activated Autologous Lymphocytes for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: adoptive immunotherapy
* Procedure: MWA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single HCC of 5 cm or smaller; three or fewer multiple HCC with a maximum dimension of 3 cm or less; absence of portal vein thrombosis or extrahepatic metastases; Child-Pugh classification A or B; tumor accessible via a percutaneous approach. white blood cell count >2 x 109/L, platelet count >40 x 109/L,serum creatinine <110 μmol/L, aspartate aminotransferase <3 times the upper limit, serum bilirubin <2.5 times the upper limit, prothrombin time <19 seconds. Exclusion Criteria: pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent; active uncontrolled infection; concurrent systemic corticosteroid treatment; systemic autoimmune disease; clinically significant ischemic heart disease or cardiac failure; and chemotherapy or radiotherapy within the preceding 6 months
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MWA only<br>The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used. | Procedure: MWA<br>* ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up<br>|
| Experimental: MWA combined with immunotherapy<br>The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy. | Biological: adoptive immunotherapy<br>* HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year.The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously.<br>* Other names: cytokine induced kill cell;Procedure: MWA<br>* ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test. |  | up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test |  | up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell