Trial | NCT03674073  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    24
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.
Study Started
Oct 15
2018
Anticipated
Primary Completion
Oct 15
2020
Anticipated
Study Completion
Dec 15
2020
Anticipated
Last Update
Oct 18
2018

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 names: Personalized Neoantigen-based Dendritic Cell Vaccine

Procedure Microwave Ablation

ALL the HCC patients will be treated by Microwave Ablation.

Microwave Ablation + Neoantigen Vaccines Experimental

The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.

Microwave Ablation Active Comparator

The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.

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.
No Results Posted