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

NCT03674073 | Completed Phase 1 DMC

• 1 other identifier: LKSM001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. After receiving information on both treatment options, eligible participants selected, according to their preference, either microwave ablation followed by Neo-DC vaccination or microwave ablation alone

Conditions

Hepatocellular Carcinoma; Liver Cancer, Adult

Keywords

Neoantigen; Vaccine; Dendritic Cell; Personalized; Liver cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Number of participants alive at 2 years

  2 years

• Progression-free survival at 2 years

  2 years

Study Arms (2)

Microwave Ablation + Neoantigen Vaccines

EXPERIMENTAL

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

Biological: Neoantigen Vaccines; Procedure: Microwave Ablation

Microwave Ablation

ACTIVE COMPARATOR

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

Procedure: Microwave Ablation

Interventions

Neoantigen Vaccines BIOLOGICAL

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.

Also known as: Personalized Neoantigen-based Dendritic Cell Vaccine

Microwave Ablation + Neoantigen Vaccines

Microwave Ablation PROCEDURE

ALL the HCC patients will be treated by Microwave Ablation.

Microwave Ablation; Microwave Ablation + Neoantigen Vaccines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<3.
• ECOG score \< 2, Child-Pugh classification A or B.
• The participants freely sign informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Likang Life Sciences Holdings Limited: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: October 15, 2018
• Primary Completion: October 15, 2020
• Study Completion: July 7, 2023
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (1)