Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Immunotherapy. 2021 Apr;13(5):371-385. doi: 10.2217/imt-2020-0278. Epub 2021 Feb 2.
Two peptide cocktail vaccines using glypican-3, WD-repeat-containing protein up-regulated in hepatocellular carcinoma (HCC) and nei endonuclease VIII-like three epitopes were evaluated in advanced HCC in two Phase I studies. Study 1 evaluated dose-limiting toxicities (DLTs) of peptides 1-3 (HLA-A24-restricted) and study 2 evaluated DLTs of peptides 1-6 (HLA-A24 or A02-restricted). Overall, 18 and 14 patients were enrolled in studies 1 and 2, respectively. No DLTs were observed up to 7.1 mg of the vaccine cocktail. No complete response/partial response was observed. Stable disease was reported in nine and five patients with a disease control rate of 52.9% and 35.7% in studies 1 and 2, respectively. Both vaccines showed good tolerability and potential usefulness against HCC. Clinical trial registration: JapicCTI-121933; JapicCTI-142477.
两种使用糖蛋白 3（glypican-3）和 WD 重复蛋白上调的肽鸡尾酒疫苗，这两种蛋白在肝癌（HCC）中上调，含有内核酸酶 VIII 样三个表位，在两项 I 期研究中评估了晚期 HCC 的疗效。研究 1 评估了肽 1-3（HLA-A24 限制性）的剂量限制毒性（DLTs），研究 2 评估了肽 1-6（HLA-A24 或 A02 限制性）的 DLTs。总体而言，研究 1 和研究 2 分别招募了 18 名和 14 名患者。在高达 7.1 毫克的疫苗鸡尾酒中没有观察到 DLTs。没有完全缓解/部分缓解。研究 1 和研究 2 中分别有 9 名和 5 名患者报告疾病稳定，疾病控制率为 52.9%和 35.7%。两种疫苗均显示出良好的耐受性和对 HCC 的潜在疗效。临床试验注册：JapicCTI-121933；JapicCTI-142477。
