Liver Neoplasms
Conditions
Keywords
dendritic cell, liver cancer, immunotherapy
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.
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.
Interventions
BIOLOGICALdendritic cells
autologous dendritic cell vaccination
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
advanced HCC patients with dendritic cell vacination
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Related Adverse Events | up to 48 months. | To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events. |
| Objective Tumor Response | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Enhancement of Immunity | 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). |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORWei-Chen Lee, MD
Chang Gung Memorial Hospital
Outcome results
None listed