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

January 4, 2024 updated by: Wei-Chen Lee, Chang Gung Memorial Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 ≥ 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure: injection of the cell therapy product

Procedures per cycle (total of 3 cycles):

8 days before autologous cell injection: Cytapheresis - Autologous cell injection - 2 days after cell injection: lab assessment.
Biological: Autologous Dendritic Cell
Biological: Immunotherapy with dendritic cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: From date of randomization untill the date of radiographic tumor assessment confirm tumor recurrence, assessed up to 3 years
From date of randomization untill the date of radiographic tumor assessment confirm tumor recurrence, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2024

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)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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