Clinical trial · Interventional
Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection - Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Dendritic Cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Dendritic Cell Therapy
- description
- 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.
- interventionNames
- Biological: Autologous Dendritic Cell
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of surgery to death from any cause, assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.References
Publications (0)
Data not yet available