Status:
NOT_YET_RECRUITING
Dendritic Cell Vaccination to Prevent Hepatocellular Carcinoma Recurrence After Liver Resection-phase II Clinical Trial
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
Hepatocellular carcinoma (HCC) is the most common primary liver tumors. Surgical resection remains the first choice of early stage HCC because the result is superior to other treatments and not limite...
Eligibility Criteria
Inclusion
- 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 ≥ 101 \[Hepatitis, score 57; platelet \< 100x103 , score72 ; multiple tumors, score 69 ; cirrhosis, score 62 ; microvascular invasion, score 100 ; total tumor volume \> 43.3cm3 ,score 90\]
- 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 participates must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
- The participates must agree to harvest and preserve tumor specimens during operation.
Exclusion
- Subjected having other malignancy except HCC are excluded.
- Uncontrolled or clinical significant cardiac diseases.
- Positive for HIV.
- Active bacterial of fungal infections.
- Prior chemotherapy within one month.
- Use of other investigational drug 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 reginal therapy within one month.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06193733
Start Date
February 19 2024
End Date
February 1 2028
Last Update
January 5 2024
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