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

Phase 1

• Conditions: Hepatocellular Carcinoma; Liver Cancer, Adult
• Interventions: Biological: Neoantigen Vaccines; Procedure: Microwave Ablation

• Registration Number: NCT03674073
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Status Verified: 2018-10
• Study Start: 2018-10-15
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18
• Primary Completion: 2020-10-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave Ablation + Neoantigen Vaccines	Microwave Ablation	The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
Microwave Ablation	Microwave Ablation	The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
Microwave Ablation + Neoantigen Vaccines	Neoantigen Vaccines	The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.

Primary Outcome Measures

Name	Time	Method
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.	1 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China