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A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674073
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Likang Life Sciences Holdings Limited
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Brief Summary:
This is a single institution, open-label, multi-arm, pilot study of a personalized neoantigen-based dendritic cell (DC) vaccine combined with microwave ablation in subjects with Hepatocellular Carcinoma (HCC). Patients with HKLC stage IIa HCC are eligible for enrollment. In this study, the investigators are looking at the safety, feasibility of the personalized neoantigen-based DC vaccine combined with microwave ablation as well as the T cell immune response to the vaccine.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer, Adult Biological: Neoantigen Vaccines Procedure: Microwave Ablation Phase 1

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microwave Ablation + Neoantigen Vaccines
The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
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.
Procedure: Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of participants alive at 2 years [ Time Frame: 2 years ]
  3. 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
Criteria

Inclusion Criteria:

  1. Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa.
  2. Age is greater than 18 years old, male or female.
  3. The tumor size is 3cm-5cm, and the lesions are <3.
  4. ECOG score < 2, Child-Pugh classification A or B.
  5. The participants freely sign informed consent;

Exclusion Criteria:

  1. Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
  2. Portal vein thrombosis or extrahepatic metastases;
  3. 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.
  4. Active uncontrolled infection;
  5. Concurrent systemic corticosteroid treatment
  6. Primary immunodeficiency or systemic autoimmune disease; being treated with immunosuppressive drugs for other diseases;
  7. Clinically significant ischemic heart disease or cardiac failure;
  8. The investigator believes that there are other reasons that are not suitable for inclusion.

Information from the National Library of Medicine

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


Contacts
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Contact: Jie Yu, Doctor 8610-66939530 yu-jie301@hotmail.com
Contact: Li Chen, Doctor 8610-84182969-808 Chenli@likanglife.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jie Yu, Doctor    8610-66939530    yu-jie301@hotmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Likang Life Sciences Holdings Limited
Investigators
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Principal Investigator: Ping Liang, Doctor Chinese PLA General Hospial
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ping Liang, Chinese PLA General Hospital:
Neoantigen
Vaccine
Dendritic Cell
Personalized
Liver cancer
Additional relevant MeSH terms:
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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