Hepatocellular CarcinomaPhase 2NCT06193733
Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial
A Phase 2 study testing Autologous Dendritic Cell in people with Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary liver tumor. Surgical resection remains the first choice for early-stage HCC because the result is superior to other treatments and not limited to liver donation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Autologous Dendritic Cell
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are $\ge 101$ [Hepatitis, score 57; platelet $< 100\times10^3$, score 72; multiple tumors, score 69; cirrhosis, score 62; microvascular invasion, score 100; total tumor volume $> 43.3\text{cm}^3$, score 90].
- Age ≧20 years old and sign informed consent.
- BCLC stage A-C
- Child-Pugh sore ≤ 6
- Percentage of lymphocytes in peripheral blood ≧12%.
- Performance status ECOG ≦2
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- AST and ALT ≦ 5x upper limit of normal.
- Platelet ≥ 80000/mm3
- WBC ≥ 3000/uL
- RBC ≥ 2.5x106/uL
- eGFR ≥ 30ml/min/1.73m2
- The patients must be disease-free after liver resection, which is confirmed by dynamic CT or MRI within 14 days.
- The participants must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
- The participants must agree to harvest and preserve tumor specimens during operation.
Who cannot join
- Subjected having other malignancies except HCC are excluded.
- Uncontrolled or clinically significant cardiac diseases.
- Positive for HIV.
- Active bacterial of fungal infections.
- Prior chemotherapy within one month.
- Use of other investigational drugs within one month.
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- Subjects with systemic steroid treatment within 14 days.
- Subjects in the status of immune deficiency.
- Subjects in the status of autoimmune diseases.
- Subjects with long-term use of immunosuppressive agents.
- Subjects with checkpoint inhibitor immunotherapy within one month.
- Subjects with local regional therapy within one month.
Trial locations and contacts
1 site in 1 country.
About this study
Hepatocellular carcinoma (HCC) is the most common primary liver tumor. Surgical resection remains the first choice for early-stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized because the tumor recurrence rate is more than 50% in 5 years although the tumors are completely resected. In our large-scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease-free survival were 73.7%, 58.3% and 53.3%, respectively. Currently, there are no effective treatments used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DCs) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DCs pulsed with tumor-associated antigens can be used to conduct tumor-specific immunotherapy. Thereafter, DCs pulsed with HCC tumor antigens may be used as an adjuvant therapy to prevent HCC recurrence.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Autologous Dendritic Cell
- Keywords
- Hepatocellular Carcinoma, Recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Dendritic CellBiological
Biological: Immunotherapy with dendritic cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous Dendritic Cell Therapy | Experimental | Participants will receive a total of 3 courses of autologous dendritic cell vaccination. For each course, peripheral blood (50-60 ml) is drawn for dendritic cell culture, followed by an intravenous injection of the cultured dendritic cells. Receives: Biological: Autologous Dendritic Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years
Secondary outcomes (1)
Overall survival
Measured: From date of surgery to death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- 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 Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193733
- Sponsor's protocol ID
- 202200329A0
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06193733
- Acronym / sponsor ID
- 202200329A0
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 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
- 5 Jan 2024 (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.
Hepatocellular carcinoma (HCC) is the most common primary liver tumor. Surgical resection remains the first choice for early-stage HCC because the result is superior to other treatments and not limited to liver donation. However, liver resection is criticized because the tumor recurrence rate is more than 50% in 5 years although the tumors are completely resected. In our large-scale study including 1639 patients with liver resection for HCC, the 1-, 3-, and 5-year disease-free survival were 73.7%, 58.3% and 53.3%, respectively. Currently, there are no effective treatments used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DCs) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DCs pulsed with tumor-associated antigens can be used to conduct tumor-specific immunotherapy. Thereafter, DCs pulsed with HCC tumor antigens may be used as an adjuvant therapy to prevent HCC recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Dendritic Cell Therapy | Experimental | Biological: Autologous Dendritic CellParticipants will receive a total of 3 courses of autologous dendritic cell vaccination. For each course, peripheral blood (50-60 ml) is drawn for dendritic cell culture, followed by an intravenous injection of the cultured dendritic cells. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are $\ge 101$ [Hepatitis, score 57; platelet $< 100\times10^3$, score 72; multiple tumors, score 69; cirrhosis, score 62; microvascular invasion, score 100; total tumor volume $> 43.3\text{cm}^3$, score 90].
- Age ≧20 years old and sign informed consent.
- BCLC stage A-C
- Child-Pugh sore ≤ 6
- Percentage of lymphocytes in peripheral blood ≧12%.
Key exclusion criteria (12 listed)
- Subjected having other malignancies except HCC are excluded.
- Uncontrolled or clinically significant cardiac diseases.
- Positive for HIV.
- Active bacterial of fungal infections.
- Prior chemotherapy within one month.
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 |
|---|---|---|
| Autologous Dendritic CellBiological: Immunotherapy with dendritic cells | Biological | Autologous Dendritic Cell Therapy |
Primary outcome
Disease-free survival
Time frame: From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years
1 secondary outcome
Overall survival
Time frame: From date of surgery to death from any cause, assessed up to 3 years
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Autologous Dendritic Cell in people with Hepatocellular Carcinoma, 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 14 inclusion and 12 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?
Disease-free survival (time frame: From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years). 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.