Hepatocellular CarcinomaPhase 1NCT03674073
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
A Phase 1 study testing Neoantigen Vaccines and Microwave Ablation in people with Hepatocellular Carcinoma and Liver Cancer, Adult, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, Adult
- What is being tested?
- Neoantigen Vaccines and Microwave Ablation
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 7 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa.
- Age is greater than 18 years old, male or female.
- The tumor size is 3cm-5cm, and the lesions are <3.
- ECOG score < 2, Child-Pugh classification A or B.
- The participants freely sign informed consent;
Who cannot join
- Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
- Portal vein thrombosis or extrahepatic metastases;
- White blood cell count <2 x 10e9/L, platelet count <40 x 10e9/L, serum creatinine >110 mol/L, aspartate aminotransferase >3 times upper limit, serum bilirubin > 2.5 times upper limit, prothrombin time> 19 seconds.
- Active uncontrolled infection;
- Concurrent systemic corticosteroid treatment
- Primary immunodeficiency or systemic autoimmune disease; being treated with immunosuppressive drugs for other diseases;
- Clinically significant ischemic heart disease or cardiac failure;
- The investigator believes that there are other reasons that are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Safety, Feasibility, and Immunogenicity of Personalized Neoantigen-based Dendritic Cell Vaccine in Combination With Microwave Ablation to Treat Hepatocellular Carcinoma
This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. After receiving information on both treatment options, eligible participants selected, according to their preference, either microwave ablation followed by Neo-DC vaccination or microwave ablation alone
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Adult
- Being tested
- Neoantigen Vaccines, Microwave Ablation
- Keywords
- Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen VaccinesBiological
Also called Personalized Neoantigen-based Dendritic Cell Vaccine
HCC (3cm≤D ≤5 cm, fewer than three tumors) patients were treated with Microwave Ablation and 7 courses of neoantigen-based DC vaccines.The first neoantigen-based DC vaccine injection will take place up to 30 days following the completion of Microwave Ablation. The day of the first vaccine injection will be referred to as Day 1.The schedule of vaccination is Day 1, Day 8, Day 15, Day 22, Day 50, Day78, Day106.
Microwave AblationProcedure or surgery
ALL the HCC patients will be treated by Microwave Ablation.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation + Neoantigen Vaccines | Experimental | The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines. Receives: Biological: Neoantigen Vaccines; Procedure: Microwave Ablation |
| Microwave Ablation | Active comparator | The HCC patients will be treated only by Microwave Ablation.No vaccine will be used. Receives: Procedure: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of neoantigen-based DC vaccine as measured by the number of subjects experiencing each type of adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: 1 years
Secondary outcomes (3)
Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.
Measured: 2 years
Number of participants alive at 2 years
Measured: 2 years
Progression-free survival at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Oct 2018
- Primary completion15 Oct 2020
- Study completion7 Jul 2023
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Likang Life Sciences Holdings Limited
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674073
- Sponsor's protocol ID
- LKSM001
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2018
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety, Feasibility, and Immunogenicity of Personalized Neoantigen-based Dendritic Cell Vaccine in Combination With Microwave Ablation to Treat Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03674073
- Acronym / sponsor ID
- LKSM001
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Adult
- Keywords
- Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Likang Life Sciences Holdings Limited
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 17 Sep 2018 (actual)
- 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.
This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. After receiving information on both treatment options, eligible participants selected, according to their preference, either microwave ablation followed by Neo-DC vaccination or microwave ablation alone
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation + Neoantigen Vaccines | Experimental | Biological: Neoantigen Vaccines, Procedure: Microwave AblationThe HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines. |
| Microwave Ablation | Active comparator | Procedure: Microwave AblationThe HCC patients will be treated only by Microwave Ablation.No vaccine will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa.
- Age is greater than 18 years old, male or female.
- The tumor size is 3cm-5cm, and the lesions are <3.
- ECOG score < 2, Child-Pugh classification A or B.
- The participants freely sign informed consent;
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
- Portal vein thrombosis or extrahepatic metastases;
- White blood cell count <2 x 10e9/L, platelet count <40 x 10e9/L, serum creatinine >110 mol/L, aspartate aminotransferase >3 times upper limit, serum bilirubin > 2.5 times upper limit, prothrombin time> 19 seconds.
- Active uncontrolled infection;
- Concurrent systemic corticosteroid treatment
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 |
|---|---|---|
| Neoantigen VaccinesAlso: Personalized Neoantigen-based Dendritic Cell VaccineHCC (3cm≤D ≤5 cm, fewer than three tumors) patients were treated with Microwave Ablation and 7 courses of neoantigen-based DC vaccines.The first neoantigen-based DC vaccine injection will take place up to 30 days following the completion of Microwave Ablation. The day of the first vaccine injection will be referred to as Day 1.The schedule of vaccination is Day 1, Day 8, Day 15, Day 22, Day 50, Day78, Day106. | Biological | Microwave Ablation + Neoantigen Vaccines |
| Microwave AblationALL the HCC patients will be treated by Microwave Ablation. | Procedure or surgery | Microwave Ablation, Microwave Ablation + Neoantigen Vaccines |
Primary outcome
Safety of neoantigen-based DC vaccine as measured by the number of subjects experiencing each type of adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 1 years
3 secondary outcomes
Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.
Time frame: 2 years
Number of participants alive at 2 years
Time frame: 2 years
Progression-free survival at 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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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. This study is not recruiting at the moment.
Ping Liang, Doctor principal investigator
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 1 study testing Neoantigen Vaccines and Microwave Ablation in people with Hepatocellular Carcinoma and Liver Cancer, Adult, 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 8 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: finished, as of the sponsor's last update on 27 Aug 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of neoantigen-based DC vaccine as measured by the number of subjects experiencing each type of adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. (time frame: 1 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 27 Aug 2026.