Clinical trial NCT02851784: Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma
Official title: Combination Therapy of Microwave Ablation and Expanding Activated Autologous Lymphocytes for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
ablation
immunotherapy
cytokine induced kill cell
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 8 years
Secondary outcomes:
measure: 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
timeFrame: up to 8 years
Other outcomes:
measure: 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
timeFrame: up to 8 years
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospial
name: Ping Liang, Dr.
role: STUDY_DIRECTOR
References: