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Completed

NCT Number: NCT03674073

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • The investigator believes that there are other reasons that are not suitable for inclusion.

Treatment and study plan

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.

Other names: Personalized Neoantigen-based Dendritic Cell Vaccine

Microwave ablation

Procedure

ALL the HCC patients will be treated by Microwave Ablation.

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.

    Time frame: 1 years

Secondary outcomes

  1. Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.

    Time frame: 2 years

  2. Number of participants alive at 2 years

    Time frame: 2 years

  3. Progression-free survival at 2 years

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Likang Life Sciences Holdings Limited

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Sep 17, 2018
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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