NCT07726329

Brief Summary

The prognosis of advanced hepatocellular carcinoma is poor. In this study, the eligible patients will be treated by tumor antigen-pulsed autologous dendritic cells and followed by TACE. The end points are to see tumor response and patient survival.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Jul 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2019Feb 2028

Study Start

First participant enrolled

July 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
6.1 years until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

8.6 years

First QC Date

June 4, 2020

Last Update Submit

July 22, 2026

Conditions

Liver Neoplasms

Keywords

dendritic cellliver cancerimmunotherapy

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Related Adverse Events

    To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.

    up to 48 months.

  • Objective Tumor Response

    To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.

    From date of first treatment until the date of first documented progression, assessed up to 48 months.

Secondary Outcomes (2)

  • Overall Survival (OS)

    From date of first treatment to death from any cause, assessed up to 48 months.

  • Enhancement of Immunity

    Baseline and at specified intervals up to 48 months.

Study Arms (1)

dendritic cell treatment

EXPERIMENTAL

phase 2, one treatment arm

Biological: dendritic cells

Interventions

dendritic cellsBIOLOGICAL

autologous dendritic cell vaccination

dendritic cell treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: \>80000/ul; anticipated survival \> 3 months, measurable tumors.

You may not qualify if:

  • HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Gung Memorial Hospital

Taoyuan, 33357, Taiwan

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Wei-Chen Lee, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: advanced HCC patients with dendritic cell vacination
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Department of General Surgery

Study Record Dates

First Submitted

June 4, 2020

First Posted

July 24, 2026

Study Start

July 1, 2019

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)