NCT03674073

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

September 14, 2018

Last Update Submit

October 16, 2018

Conditions

Hepatocellular CarcinomaLiver Cancer, Adult

Keywords

NeoantigenVaccineDendritic CellPersonalizedLiver 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 VaccinesProcedure: 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 VaccinesBIOLOGICAL

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 AblationPROCEDURE

ALL the HCC patients will be treated by Microwave Ablation.

Microwave AblationMicrowave Ablation + Neoantigen Vaccines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ping Liang, Doctor

    Chinese PLA General Hospial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

8610-66939530yu-jie301@hotmail.com

Li Chen, Doctor

CONTACT

8610-84182969-808Chenli@likanglife.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
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

December 15, 2020

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

CN(1)