A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
NCT ID: NCT03674073
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2018-10-15
2020-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Microwave Ablation + Neoantigen Vaccines
The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
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.
Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation.
Microwave Ablation
The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation.
Interventions
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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.
Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Likang Life Sciences Holdings Limited
UNKNOWN
Chinese PLA General Hospital
OTHER
Responsible Party
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Ping Liang
Professor
Principal Investigators
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Ping Liang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospial
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LKSM001
Identifier Type: -
Identifier Source: org_study_id
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