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
Patients with HCC (tumor diameter ≤5 cm and fewer than three tumors) underwent radical MWA followed by cellular immunotherapy. In the CIK-based cohort, patients received 4-6 courses annually, starting at 2, 4, 6, 10, 14, and 18 weeks after MWA, followed by treatment every 12 weeks. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were administered intraperitoneally, and CIK cells were infused intravenously. In the NK-cell cohort, patients received six NK-cell infusions at 2-week intervals after complete MWA and normalization of body temperature. NK cells were expanded ex vivo from autologous peripheral blood, allogeneic peripheral blood, or umbilical cord blood.
Interventions
BIOLOGICALadoptive immunotherapy
Patients with HCC (tumor diameter ≤5 cm and fewer than three tumors) underwent radical MWA followed by cellular immunotherapy. In the CIK-based cohort, patients received 4-6 courses annually, starting at 2, 4, 6, 10, 14, and 18 weeks after MWA, followed by treatment every 12 weeks. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were administered intraperitoneally, and CIK cells were infused intravenously. In the NK-cell cohort, patients received six NK-cell infusions at 2-week intervals after complete MWA and normalization of body temperature. NK cells were expanded ex vivo from autologous peripheral blood, allogeneic peripheral blood, or umbilical cord blood.
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 |
Countries
China
Contacts
CONTACTJie Yu, Dr.
CONTACTMengjuan Mu, Ms.
STUDY_DIRECTORPing Liang, Dr.
Chinese PLA General Hospial
Outcome results
None listed