Dendritic Cell Vaccine Shows Preliminary Activity in Advanced HCC

Results from the trial revealed that the median PFS per RECIST v1.1 criteria was 10.4 months among patients in those who did not receive the vaccine vs 18.6 months in those who did.

Transarterial chemoembolization (TACE) enriched with dendritic cell (DC) infusions exhibited a preliminary advantage vs TACE alone in patients with intermediate-stage hepatocellular carcinoma (HCC), according to results from the phase 2 ImmunoTACE trial (2011-001690-62) published in Clinical Cancer Research.¹

Results from the trial revealed that the median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria was 10.4 months among patients in those who did not receive DC vs 18.6 months in those who did (HR, 0.43; 95% CI, 0.20-0.93; P = .016). After adjusting for Hepatoma Arterial-embolization Prognostic (HAP) score, the difference in median PFS remained (HR, 0.57; P = .099).

In the respective arms, the median overall survival (OS) was 21.5 months vs 25.7 months, the difference for which did not reach statistical significance (HR, 0.61; 95% CI, 0.27-1.38). Furthermore, the objective response rate (ORR) was 29.2% in patients treated with TACE only and 54.2% in those treated with DC for a difference of –25.0% (95% CI, –52% to 2%). Additionally, the disease control rate (DCR) was 66.7% and 91.7%, with a difference of –25% (95% CI, –46.8% to –3.2%).

“The results from [the] phase 2 [ImmunoTACE] trial are promising and offer a potential new treatment option for patients with primary liver cancer, one of the highest causes of cancer-related death worldwide,” David Adams, MD, FRCP, FMedSci, chief investigator of the study and emeritus professor of Hepatology at the University of Birmingham, said in a news release on the study’s findings.² “As far as we know, ImmunoTACE is the first controlled clinical trial to show that a cell-based vaccine using lab-grown dendritic cells can improve patient outcomes with liver cancer. The results warrant further investigation and could, in the future, offer much-needed hope and a better treatment option for patients.”

The open-label, multicenter phase 2 trial enrolled patients 18 years and older with histologically or cytologically confirmed HCC with at least 1 unidimensional lesion and randomly assigned them 1:1 to receive TACE plus preconditioning cyclophosphamide with or without DC. Patients were stratified by etiology and treatment center.

In the first 13 patients, including 5 in the DC group, leukapheresis was performed on day 24, and TACE was given with or without DC infusion on day 31. Subsequently, patients were leukapheresed prior to day 1 of cyclophosphamide treatment, with the DC vaccine thawed prior to infusion.

Patients in both cohorts received 250 mg/m² of intravenous cyclophosphamide on days 1 and 29, followed by TACE on day 31, and further cyclophosphamide at the same dose on days 60, 90, and 120. Those in the DC group received the first vaccine delivered via intrahepatic infusion at the end of chemoembolization on day 31. Additionally, intravenous vaccines were given on days 62, 92, and 122, 2 days after cyclophosphamide dosing.

In the DC-naïve and DC-enriched cohorts, the median age was 65.0 years (IQR, 59.0-73.0) and 70.5 years (IQR, 65.0-74.0), and 88.9% vs 89.3% were male. Furthermore, 59.3% vs 53.6% had an ECOG performance status of 0, 74.1% vs 96.4% had a Child-Pugh score of 5, and 50.0% vs 33.3% had a disease focus of 2. The most common etiologies included alcohol (31.0% vs 26.5%) and NASH (27.6% vs 26.5%). Most patients had an ALBI score of 1 (66.7% vs 64.3%), and most patients had a HAP score of B (48.1% vs 46.4%).

The primary end point was PFS. Secondary end points included OS, radiologic response, toxicity, and immune response.

Safety data revealed that the incidence and severity of adverse effects (AEs) were not significantly different between the 2 cohorts. The most grade 3 or higher AEs included lymphocyte count decreased, neutrophil count decreased, white blood cell count decreased, and alanine aminotransferase level increased. Additionally, the most common AEs related to DC included chills (30%), fatigue (22%), and nausea (22%); they were all grades 1 or 2 in severity.

References

1. Ma YT, Zuo J, Kirkham A, et al. Addition of dendritic cell vaccination to conditioning cyclophosphamide and chemoembolization in patients with hepatocellular carcinoma: the immunoTACE trial. Clin Cancer Res. 2025;31:3412-3423. doi:10.1158/1078-0432.CCR-25-0142
2. Adding cell-based vaccine to liver cancer therapy slows cancer progression in patients. News release. University of Birmingham. August 26, 2025. Accessed August 27, 2025. https://tinyurl.com/yc5ysajy