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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 1

Conditions: Liver Cancer, Adult; Hepatocellular Carcinoma

Treatments: Procedure: Microwave Ablation; Biological: Neoantigen Vaccines

Study type: Interventional

Funder types: Other

Identifiers

NCT03674073

LKSM001

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Microwave Ablation + Neoantigen Vaccines

Experimental group

Description:

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

Treatment:

Biological: Neoantigen Vaccines

Procedure: Microwave Ablation

Microwave Ablation

Active Comparator group

Description:

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

Treatment:

Procedure: Microwave Ablation