NCT06193733Active, not recruitingPhase 2

Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 74 (estimated)
First submitted: 18 Dec 2023
Start date: 1 Jul 2019
Primary completion date: 29 Feb 2028
Lead sponsor: Chang Gung Memorial Hospital
Diseases: Liver and biliary tract cancer
NCT number: NCT06193733

What you commit to

Study type: Interventional · Phase 2
Planned participants: 74
From 1 Jul 2019 to the primary completion date, 29 Feb 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior chemotherapy within one month.
Use of other investigational drugs within one month.
Subjects with systemic steroid treatment within 14 days.
Subjects with checkpoint inhibitor immunotherapy within one month.
Subjects with local regional therapy within one month.

Other illness

Subjected having other malignancies except HCC are excluded.
Uncontrolled or clinically significant cardiac diseases.
Positive for HIV.
Active bacterial of fungal infections.
Subjects in the status of autoimmune diseases.

Other

Subjects in the status of immune deficiency.
Subjects with long-term use of immunosuppressive agents.

Who the study is looking for

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
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.

Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Chang Gung Medical Foundation Coordinator of this site? Confirm its status	Taiyuan	Taiwan	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.