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Phase 1 Trial With the Cell-Based Immune Primer Ilixadencel, Alone, and Combined With Sorafenib, in Advanced Hepatocellular Carcinoma
Sahlgrens Univ Hosp, Transplantat Ctr, Gothenburg, Sweden;Univ Gothenburg, Inst Clin Sci, Dept Surg, Sahlgrenska Acad, Gothenburg, Sweden.
Sahlgrens Univ Hosp, Transplantat Ctr, Gothenburg, Sweden;Univ Gothenburg, Inst Clin Sci, Dept Surg, Sahlgrenska Acad, Gothenburg, Sweden.
Univ Gothenburg, Dept Radiol, Sahlgrenska Univ Hosp, Gothenburg, Sweden;Univ Gothenburg, Sahlgrenska Acad, Gothenburg, Sweden;Karolinska Univ Hosp, Dept Radiol, Huddinge, Sweden.
Univ Gothenburg, Sahlgrenska Acad, Gothenburg, Sweden;Univ Gothenburg, Dept Microbiol & Immunol, Sahgrenska Univ Hosp, Gothenburg, Sweden.
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2019 (English)In: Frontiers in Oncology, ISSN 2234-943X, E-ISSN 2234-943X, Vol. 9, p. 1-10, article id 19Article in journal (Refereed) Published
Abstract [en]

Several lines of evidence support immunotherapy in hepatocellular carcinoma (HCC). We have shown that intratumoral injections of the immune primer ilixadencel (pro-inflammatory allogeneic dendritic cells) are safe in renal-cell carcinoma. Here, we assessed ilixadencel as a single agent and combined with sorafenib in advanced HCC. Of 17 HCC patients enrolled, 12 patients received ilixadencel at the dose of 10 x 106 cells (six as monotherapy and six in combination with sorafenib), and five received ilixadencel at the dose of 20 x 106 cells as monotherapy. The primary objective was to evaluate tolerability. All patients had at least one adverse event, with 30% of such events considered as treatment-related, with one single treatment-related grade three event. The most common toxicity was grade 1 and 2 fever and chills. Eleven of 15 evaluable patients (73%) showed increased frequency of tumor-specific CD8(+) T cells in peripheral blood. Overall one patient had a partial response (with ilixadencel as monotherapy), and five had stable disease as overall best response per mRECIST. The median time to progression was 5.5 months, and overall survival ranged from 1.6 to 21.4 months. Our study confirms the safety of ilixadencel as single agent or in combination with sorafenib and indicates tumor-specific immunological responses in advanced HCC.

Place, publisher, year, edition, pages
2019. Vol. 9, p. 1-10, article id 19
Keywords [en]
hepatocellular carcinoma, cell therapy, immunotherapy, allogeneic, dendritic cells, ilixadencel, sorafenib
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-375811DOI: 10.3389/fonc.2019.00019ISI: 000456175600001PubMedID: 30719425OAI: oai:DiVA.org:uu-375811DiVA, id: diva2:1286807
Available from: 2019-02-07 Created: 2019-02-07 Last updated: 2019-02-07Bibliographically approved

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