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

StatusActive, Not Recruiting
PhasePhase 2
Started2019-07-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
Study Identification, Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial status changed: Not Yet Recruiting → Active, Not Recruiting
Start dateestimated 2024-02-19→confirmed 2019-07-01
Eligibility criteria+25 characters
[...] gures, and the risk nomogram scores of tumor recurrence are ≥$\ge 101$ [Hepatitis, score 57; platelet $< 100x103 100\times10^3$, score72score 72; multiple tumors, score 69; cirrhosis, score 62; microvascular invasion, score 100; total tumor volume $> 43.3cm33\text{cm}^3$, ,score 90]. Age ≧20 years old and sign informed consent. BCLC stage A-C [...] which is confirmed by dynamic CT or MRI within 14 days. The participatesparticipants must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely. The participatesparticipants must agree to harvest and pre [...] [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study title+2 characters
Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection -phase Phase II Clinical Trial
2024-01-04
Original filing
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.
Trial Details
NCT Number NCT06193733
Lead Sponsor Chang Gung Memorial Hospital
Conditions Hepatocellular Carcinoma
Enrollment 74 participants
Start Date 2019-07-01
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-24