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

Chinese PLA General Hospital1 site in 1 country24 target enrollmentOctober 15, 2018

ConditionsHepatocellular Carcinoma Liver Cancer, Adult

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Chinese PLA General Hospital
Enrollment: 24
Locations: 1
Primary Endpoint: 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.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2018

End Date

December 15, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Ping Liang

Professor

Chinese PLA General Hospital

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 \<
•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.

Outcomes

Primary Outcomes

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 Outcomes

Number of participants alive at 2 years(2 years)
Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.(2 years)
Progression-free survival at 2 years(2 years)