A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT03674073 |
Recruitment Status : Unknown
Verified October 2018 by Ping Liang, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : September 17, 2018
Last Update Posted : October 18, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Liver Cancer, Adult | Biological: Neoantigen Vaccines Procedure: Microwave Ablation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | October 15, 2018 |
Estimated Primary Completion Date : | October 15, 2020 |
Estimated Study Completion Date : | December 15, 2020 |
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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Biological: Neoantigen Vaccines
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 Name: Personalized Neoantigen-based Dendritic Cell Vaccine Procedure: Microwave Ablation ALL the HCC patients will be treated by Microwave Ablation. |
Active Comparator: Microwave Ablation
The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
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Procedure: Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674073
Contact: Jie Yu, Doctor | 8610-66939530 | yu-jie301@hotmail.com | |
Contact: Li Chen, Doctor | 8610-84182969-808 | Chenli@likanglife.com |
China, Beijing | |
Chinese PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Jie Yu, Doctor 8610-66939530 yu-jie301@hotmail.com |
Principal Investigator: | Ping Liang, Doctor | Chinese PLA General Hospial |
Responsible Party: | Ping Liang, Professor, Chinese PLA General Hospital |
ClinicalTrials.gov Identifier: | NCT03674073 |
Other Study ID Numbers: |
LKSM001 |
First Posted: | September 17, 2018 Key Record Dates |
Last Update Posted: | October 18, 2018 |
Last Verified: | October 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoantigen Vaccine Dendritic Cell Personalized Liver cancer |
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |