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Active, Not Recruiting

NCT Number: NCT07726329

Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Neoplasms Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang-Gung Memorial Hospital

Taoyuan, 33357, Taiwan

About this study

Hepatocellular carcinoma (HCC) is a high malignant tumor with a rapidly progressive clinical course. Surgery is the first choice of the treatment. However, most HCC patients have numerous tumors upon diagnosis, which are not possible to be treated by surgical resection. Currently, several treatment options are applied to treat unresectable HCC, including transcartheter arterial chemoembolization (TACE), percutaneous ethanol injection, radiofrequency ablation, chemotherapy and radiotherapy. Nevertheless, the therapeutic results of these treatment modalities are unsatisfied.

TACE is frequently applied to treat the patients with unresectable HCCs in daily practice. Embolization blocks the arterial blood supply to the tumor and results in tumor necrosis. However, clinical benefits are limited, and the response rate is only 30% Dendritic cells (DC), the most potent antigen-presenting cells, serve as a cancer vaccine to conduct an antigen-specific anti-tumor therapy. Dendritic cell-based immunotherapy has been applied to treat advanced HCC in our previous study. The clinical results of this study verify the feasibility of DC-based immunotherapy for HCC. However, the results are still unsatisfied.

In this proposal, investigators are going to treatment the patients having unresectable HCCs with DC vaccination followed by TACE. DC vaccination can provoke antigen-specific immunity and induce memory T-cells. TACE following DC vaccination may further promote T-cell immunity to treat cancer. Therefore, the specific aims in this study are:

  • To determine whether DC vaccination followed by TACE can treat HCC effectively in a clinical trial.
  • To determine whether DC vaccination can provoke memory T cells and following TACE can further promote anti-HCC immunity.

The achievement of this clinical trial will help to establish a new strategy for the treatment of unresectable HCC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dendritic Cells

Biological

autologous dendritic cell vaccination

Primary outcomes

  1. Incidence of Treatment-Related Adverse Events

    Time frame: up to 48 months.

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

  2. Objective Tumor Response

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

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

Secondary outcomes

  1. Overall Survival (OS)

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

    To examine the survival of the patients. Overall survival is defined as the time from the date of first treatment to death from any cause.

  2. Enhancement of Immunity

    Time frame: Baseline and at specified intervals up to 48 months.

    evaluate the enhancement of immunity after treatments by measuring quantitative T-cell proliferation via mixed lymphocyte reaction (MLR).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 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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