Addition of Dendritic Cell Vaccination to Conditioning Cyclophosphamide and Chemoembolization in Patients with Hepatocellular Carcinoma: The ImmunoTACE Trial.
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Embargo End Date
ICR Authors
Authors
Ma, YT
Zuo, J
Kirkham, A
Curbishley, S
Blahova, M
Rowe, AL
Bathurst, C
Mehrzad, H
Karkhanis, S
Punia, P
James, MW
Stern, N
Rao, A
Hull, D
Lowe, F
Sylla, P
Webster, L
Hussain, S
Yap, C
Palmer, D
Adams, DH
Zuo, J
Kirkham, A
Curbishley, S
Blahova, M
Rowe, AL
Bathurst, C
Mehrzad, H
Karkhanis, S
Punia, P
James, MW
Stern, N
Rao, A
Hull, D
Lowe, F
Sylla, P
Webster, L
Hussain, S
Yap, C
Palmer, D
Adams, DH
Document Type
Journal Article
Date
2025-08-14
Date Accepted
2025-06-06
Abstract
PURPOSE: A previous study by our group using dendritic cells (DC) pulsed ex vivo with the lysate of the HepG2 cell line showed evidence of antigen-specific T-cell responses in some patients with advanced hepatocellular carcinoma. The ImmunoTACE trial evaluated the preliminary activity of this vaccine in combination with transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma. PATIENTS AND METHODS: A randomized phase II trial was conducted in three tertiary referral centers in the United Kingdom. Eligible patients were randomly assigned in a 1:1 ratio to TACE + preconditioning cyclophosphamide or to TACE + preconditioning cyclophosphamide + DC infusions. The primary endpoint was progression-free survival time using RECIST v1.1 criteria. Additional endpoints included safety and immune responses. RESULTS: Between March 2016 and October 2019, 55 patients were randomized, of whom 48 were evaluable (24 in each group). The median progression-free survival time using RECIST criteria was 18.6 months in patients treated with chemoembolization + preconditioning cyclophosphamide + DC infusions compared with 10.4 months in those treated with chemoembolization + preconditioning cyclophosphamide alone (HR = 0.43; upper value of one-sided 80% confidence interval, 0.57; P = 0.016). The addition of DC infusions did not significantly increase the incidence or severity of adverse events. An enhanced antigen (α-fetoprotein)-specific immune response was observed in patients treated with DC vaccination. CONCLUSIONS: The addition of DC infusions to TACE and preconditioning cyclophosphamide has shown promising preliminary activity and merits further investigation in a larger randomized trial.
Citation
Clinical Cancer Research, 2025, 31 (16), pp. 3412 - 3423
Source Title
Clinical Cancer Research
Publisher
AMER ASSOC CANCER RESEARCH
ISSN
1078-0432
eISSN
1557-3265
Collections
Research Team
Clin Trials & Stats Unit