Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma

A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Neoplasms
• Intervention / Treatment: Biological: dendritic cells

Detailed Description

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:

1. To determine whether DC vaccination followed by TACE can treat HCC effectively in a clinical trial.
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33357
    • Chang-Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dendritic cell treatment; phase 2, one treatment arm	Biological: dendritic cells; autologous dendritic cell vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	From date of first treatment to death from any cause, assessed up to 48 months.
Enhancement of Immunity	evaluate the enhancement of immunity after treatments by measuring quantitative T-cell proliferation via mixed lymphocyte reaction (MLR).	Baseline and at specified intervals up to 48 months.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Wei-Chen Lee, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; dendritic cell; liver cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 201800519A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No