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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03674073
• Other study ID #: LKSM001
• Status: Recruiting
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2018
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 8610-66939530
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer, Adult
• Liver Neoplasms

Intervention

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.

Procedure:
• Microwave Ablation
ALL the HCC patients will be treated by Microwave Ablation.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Likang Life Sciences Holdings Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants alive at 2 years		2 years
Secondary	Progression-free survival at 2 years		2 years