Liver NeoplasmsPhase 2NCT07726329
Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma
A Phase 2 study testing dendritic cells in people with Liver Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- dendritic cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
Who cannot join
- HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Liver Neoplasms
- Being tested
- dendritic cells
- Keywords
- dendritic cell, liver cancer, immunotherapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cellsBiological
autologous dendritic cell vaccination
| Study group | Role | What they receive |
|---|---|---|
| dendritic cell treatment | Experimental | phase 2, one treatment arm Receives: Biological: dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events
To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
Measured: up to 48 months.
Objective Tumor Response
To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
Measured: From date of first treatment until the date of first documented progression, assessed up to 48 months.
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline and at specified intervals up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jul 2019
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- advanced HCC patients with dendritic cell vacination
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Chen Lee, Chang Gung Memorial Hospital
- Investigators
- Wei-Chen Lee, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726329
- Sponsor's protocol ID
- 201800519A0
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07726329
- Acronym / sponsor ID
- 201800519A0
- Conditions
- Liver Neoplasms
- Keywords
- dendritic cell, liver cancer, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- advanced HCC patients with dendritic cell vacination
| Arm | Type | Receives |
|---|---|---|
| dendritic cell treatment | Experimental | Biological: dendritic cellsphase 2, one treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
Key exclusion criteria (1 listed)
- HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dendritic cellsautologous dendritic cell vaccination | Biological | dendritic cell treatment |
Primary outcome
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.
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: From date of first treatment to death from any cause, assessed up to 48 months.
Enhancement of Immunity
Time frame: Baseline and at specified intervals up to 48 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Chen Lee, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dendritic cells in people with Liver Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events (time frame: up to 48 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.