Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

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

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).

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: MWA; Biological: adoptive immunotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MWA only; The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.	Procedure: MWA; ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
Experimental: MWA combined with immunotherapy; The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.	Procedure: MWA; ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up; 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.; Other Names: cytokine induced kill cell

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Director: Ping Liang, Dr., Chinese PLA General Hospial

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: immunotherapy; hepatocellular carcinoma; ablation; cytokine induced kill cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: liangping

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED