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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06193733
• Other study ID #: 202200329A0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 19, 2024
• Est. completion date: February 2028

Study information

• Verified date: January 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 limited to liver donation. However, liver resection is criticized that tumor recurrent 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 survival were 73.7%, 58.3% and 53.3%, respectively. Currently there are no effective treatment used as adjuvant therapy to prevent HCC recurrence. Dendritic cells (DC) are the most potent professional antigen-presenting cells, and can capture tumor antigens to provoke antigen-specific cytotoxic T-cells. DC pulsed by tumor associated antigens can be used to proceed tumor-specific immunotherapy. Thereafter, DC pulsed HCC tumor-antigens may be used as an adjuvant therapy to prevent HCC recurrence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 = 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Biological:
• Autologous Dendritic Cell
Biological: Immunotherapy with dendritic cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		From date of randomization untill the date of radiographic tumor assessment confirm tumor recurrence, assessed up to 3 years
Secondary	Overall survival		3 years