Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

September 15, 2026 updated by: Ping Liang, Chinese PLA General Hospital

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

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mengjuan Mu, Ms.
  • Phone Number: 8610-66939530

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

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.

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.
Time Frame: up to 8 years
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
Time Frame: up to 8 years
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
Time Frame: up to 8 years
up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimated)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • liangping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe