Back to resultsA Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Liver Cancer, Adult
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Neoantigen Vaccines
Microwave Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microwave Ablation + Neoantigen Vaccines
Microwave Ablation
Arm Description
The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.
Number of participants alive at 2 years
Progression-free survival at 2 years
Full Information
NCT ID
NCT03674073
First Posted
September 14, 2018
Last Updated
October 16, 2018
Sponsor
Chinese PLA General Hospital
Collaborators
Likang Life Sciences Holdings Limited
1. Study Identification
Unique Protocol Identification Number
NCT03674073
Brief Title
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Anticipated)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Likang Life Sciences Holdings Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cancer, Adult
Keywords
Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microwave Ablation + Neoantigen Vaccines
Arm Type
Experimental
Arm Description
The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
Arm Title
Microwave Ablation
Arm Type
Active Comparator
Arm Description
The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
Intervention Type
Biological
Intervention Name(s)
Neoantigen Vaccines
Other Intervention Name(s)
Personalized Neoantigen-based Dendritic Cell Vaccine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microwave Ablation
Intervention Description
ALL the HCC patients will be treated by Microwave Ablation.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Number of participants alive at 2 years
Time Frame
2 years
Title
Progression-free survival at 2 years
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Yu, Doctor
Phone
8610-66939530
Email
yu-jie301@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chen, Doctor
Phone
8610-84182969-808
Email
Chenli@likanglife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liang, Doctor
Organizational Affiliation
Chinese PLA General Hospial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yu, Doctor
Phone
8610-66939530
Email
yu-jie301@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
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