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

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 Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Liver Cancer, Adult
• Intervention / Treatment: Biological: Neoantigen Vaccines; Procedure: Microwave Ablation

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Chen, Doctor; Phone Number: 8610-84182969-808; Email: Chenli@likanglife.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Microwave Ablation + Neoantigen Vaccines; The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.	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.
ACTIVE_COMPARATOR: Microwave Ablation; The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.	Procedure: Microwave Ablation; ALL the HCC patients will be treated by Microwave Ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Likang Life Sciences Holdings Limited
• Investigators: Principal Investigator: Ping Liang, Doctor, Chinese PLA General Hospial

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2018
• Primary Completion (ANTICIPATED): October 15, 2020
• Study Completion (ANTICIPATED): December 15, 2020

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (ACTUAL): September 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Vaccine; Neoantigen; Personalized; Liver cancer; Dendritic Cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LKSM001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No