Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851784
• Other study ID #: liangping
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2009
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• adoptive 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.

Procedure:
• MWA
ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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