Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Recurrence
Brief 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.
Interventions
BIOLOGICALAutologous Dendritic Cell
Biological: Immunotherapy with dendritic cells
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | From date of surgery to death from any cause, assessed up to 3 years |
Countries
Taiwan
Outcome results
None listed