A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
August 25, 2026 updated by: Ping Liang, Chinese PLA General Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Chinese PLA General Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
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 |
|---|---|
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Experimental: Microwave Ablation + Neoantigen Vaccines
The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
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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.
Other Names:
ALL the HCC patients will be treated by Microwave Ablation.
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Active Comparator: Microwave Ablation
The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
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ALL the HCC patients will be treated by Microwave Ablation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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1 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of participants alive at 2 years
Time Frame: 2 years
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2 years
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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
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2 years
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Progression-free survival at 2 years
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ping Liang, Doctor, 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)
October 15, 2018
Primary Completion (Actual)
October 15, 2020
Study Completion (Actual)
July 7, 2023
Study Registration Dates
First Submitted
September 14, 2018
First Submitted That Met QC Criteria
September 14, 2018
First Posted (Actual)
September 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 27, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LKSM001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.