Clinical Trials List
Protocol NumberDC_clinical trial 20220311
NCT Number(ClinicalTrials.gov Identfier)NCT06193733
2023-04-12 - 2028-04-12
Phase II
Recruiting1
Dendritic cell vaccination to prevent hepatocellular carcinoma recurrence after liver resection-phase II clinical trial
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Sponsor
Linkou Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2026/09/09
Investigators and Locations
Principal Investigator
Wei-Chen Lee
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hepatocellular Carcinoma
Objectives
Reduce the tumor recurrence rate by 30% after liver resection in high-risk patients.
Test Drug
Dendritic cell
Active Ingredient
Dendritic cell
Dosage Form
6ml 液體
Dosage
(1-20)x106 /次
Endpoints
Disease-free survival
Overall survival
Overall survival
Inclution Criteria
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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
0 participants
