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Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
adoptive immunotherapy
MWA
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MWA only

MWA combined with immunotherapy

Arm Description

The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.

The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2016
Last Updated
March 2, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02851784
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MWA only
Arm Type
Active Comparator
Arm Description
The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.
Arm Title
MWA combined with immunotherapy
Arm Type
Experimental
Arm Description
The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.
Intervention Type
Biological
Intervention Name(s)
adoptive immunotherapy
Other Intervention Name(s)
cytokine induced kill cell
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
MWA
Intervention Description
ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
Primary Outcome Measure Information:
Title
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.
Time Frame
up to 8 years
Secondary Outcome Measure Information:
Title
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
Time Frame
up to 8 years
Other Pre-specified Outcome Measures:
Title
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
Time Frame
up to 8 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single HCC of 5 cm or smaller; three or fewer multiple HCC with a maximum dimension of 3 cm or less; absence of portal vein thrombosis or extrahepatic metastases; Child-Pugh classification A or B; 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: pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent; active uncontrolled infection; concurrent systemic corticosteroid treatment; systemic autoimmune disease; clinically significant ischemic heart disease or cardiac failure; and chemotherapy or radiotherapy within the preceding 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liang, Dr.
Organizational Affiliation
Chinese PLA General Hospial
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

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