Hepatocellular CarcinomaPhase 2/3NCT02851784
Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma
A Phase 2/3 study testing adoptive immunotherapy and MWA in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- adoptive immunotherapy and MWA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mengjuan Mu, Ms. contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8610-66939530, yu-jie301@hotmail.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- adoptive immunotherapy, MWA
- Keywords
- hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adoptive immunotherapyBiological
Also called cytokine induced kill cell
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.
MWAProcedure or surgery
ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
| Study group | Role | What they receive |
|---|---|---|
| MWA only | Active comparator | The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used. Receives: Procedure: MWA |
| MWA combined with immunotherapy | Experimental | The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy. Receives: Biological: adoptive immunotherapy; Procedure: MWA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 years
Secondary outcomes (1)
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
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startDec 2009
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Dr., Study director, Chinese PLA General Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851784
- Sponsor's protocol ID
- liangping
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2016
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Microwave Ablation and Expanding Activated Autologous Lymphocytes for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02851784
- Acronym / sponsor ID
- liangping
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, ablation, immunotherapy, cytokine induced kill cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWA only | Active comparator | Procedure: MWAThe HCC patients will be treated only by MWA.No adoptive immunotherapy will be used. |
| MWA combined with immunotherapy | Experimental | Biological: adoptive immunotherapy, Procedure: MWAThe HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adoptive immunotherapyAlso: cytokine induced kill cellPatients 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. | Biological | MWA combined with immunotherapy |
| MWAALL the HCC patients will be treated only by microwave ablation and then enter the follow-up | Procedure or surgery | MWA combined with immunotherapy, MWA only |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mengjuan Mu, Ms. contact
Ping Liang, Dr. study director
Chinese PLA General Hospial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing adoptive immunotherapy and MWA in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Dr. (8610-66939530, yu-jie301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.