Autologous Dendritic Cell: Biological: Immunotherapy with dendritic cells
Study 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. 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Disease-free survival — From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years
Trial sites (1)
Facility
City
Region
Status
Chang Gung Medical Foundation
Taiyuan
Taoyuan
More Chang Gung Memorial Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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