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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: Autologous Dendritic Cell

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Taiyuan, Taoyuan, Taiwan, 333
      • Chang Gung Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Dendritic Cell Therapy; 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; Biological: Immunotherapy with dendritic cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	From date of surgery until the date of radiographic tumor assessment confirming tumor recurrence, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	From date of surgery to death from any cause, assessed up to 3 years

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Pathological Conditions, Signs and Symptoms; Recurrence; Carcinoma, Hepatocellular
• Other Study ID Numbers: 202200329A0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No