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

NCT06193733 | Active Not Recruiting Phase 2

• 1 other identifier: 202200329A0
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Recurrence

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years

Secondary Outcomes (1)

• Overall survival

  From date of surgery to death from any cause, assessed up to 3 years

Study Arms (1)

Autologous Dendritic Cell Therapy

EXPERIMENTAL

Participants will receive a total of 3 courses of autologous dendritic cell vaccination. For each course, peripheral blood (50-60 ml) is drawn for dendritic cell culture, followed by an intravenous injection of the cultured dendritic cells.

Biological: Autologous Dendritic Cell

Interventions

Autologous Dendritic Cell BIOLOGICAL

Biological: Immunotherapy with dendritic cells

Autologous Dendritic Cell Therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Medical Foundation

Taiyuan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 5, 2024
• Study Start: July 1, 2019
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

TW (1)