Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell
Brief summary
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
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.
Interventions
BIOLOGICALadoptive immunotherapy
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.
PROCEDUREMWA
ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. single HCC of 5 cm or smaller; 2. three or fewer multiple HCC with a maximum dimension of 3 cm or less; 3. absence of portal vein thrombosis or extrahepatic metastases; 4. Child-Pugh classification A or B; 5. 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
1. pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent; 2. active uncontrolled infection; concurrent systemic corticosteroid treatment; 3. systemic autoimmune disease; 4. clinically significant ischemic heart disease or cardiac failure; 5. and chemotherapy or radiotherapy within the preceding 6 months
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Local tumor progress 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 |
Countries
China
Outcome results
None listed