A Phase 2 interventional study of dendritic cells in Liver Neoplasms, sponsored by Chang Gung Memorial Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
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:
The achievement of this clinical trial will help to establish a new strategy for the treatment of unresectable HCC.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 100 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
phase 2, one treatment arm
Biological: dendritic cells
autologous dendritic cell vaccination
Incidence of Treatment-Related Adverse Events
To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
Time frame: up to 48 months.
Objective Tumor Response
To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
Time frame: From date of first treatment until the date of first documented progression, assessed up to 48 months.
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.
Time frame: 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).
Time frame: Baseline and at specified intervals up to 48 months.
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital