Phase I clinical trial of peptide vaccination with URLC10 and VEGFR1 epitope peptides in patients with advanced gastric cancer.
Phase I clinical trial of peptide vaccination with URLC10 and VEGFR1 epitope peptides in patients with advanced gastric cancer.
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DOI：
10.3892/ijo.2013.2242
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发表时间：
2014-03
影响因子：
5.2
通讯作者：
Watanabe S
中科院分区：
文献类型：
--
作者：
Higashihara Y;Kato J;Nagahara A;Izumi K;Konishi M;Kodani T;Serizawa N;Osada T;Watanabe S
近年来，肽疫苗治疗作为化疗耐药、晚期、不可切除癌症的新治疗选择引起了人们的关注。在一项针对化疗难治性晚期胃癌患者的 I 期临床试验中，研究了使用 HLA-A*2402 限制性 URLC10-A24-177 和 VEGFR1-A12-9 1084 表位肽（固定 2 mg 剂量）进行肽疫苗接种的安全性。我们在入组后确定了受试者的 HLA 基因型，其结果由评估委员会保存，并且在研究完成之前不向患者和研究人员透露。主要终点是肽疫苗接种的安全性。次要终点是 HLA-A*2402 阳性组和 HLA-A*2402 阴性组之间的免疫反应和临床结果。这些肽在 28 天治疗周期的第 1、8、15 和 22 天进行皮下注射。共有 14 名患者参与了这项研究； 14 名患者中有 12 人接受了 4 次或以上疫苗接种（至少 1 个疗程）。没有患者出现严重的治疗相关不良事件。单疗程后临床反应评估结果显示，4例病情稳定，8例病情进展。 12 名患者的中位总生存时间 (MST) 为 3.9 个月。 HLA-A*2402 阳性组和 HLA-A*2402 阴性组的 MST 分别为 4.2 个月和 3.6 个月 (p= 0.9164)。这项研究的结果表明，接种 URLC10 和 VEGFR1 肽疫苗是治疗晚期胃癌的安全方法。该试验已在大学医院医疗信息网络（UMIN，编号 000002409）注册。
Peptide vaccine treatment has attracted attention in recent years as a new therapy option for chemotherapy-resistant, advanced, unresectable cancer. The safety of peptide vaccination with HLA-A*2402-restricted URLC10-A24-177 and VEGFR1-A12-9 1084 epitope peptides (fixed 2-mg dose) was investigated in a phase I clinical trial of patients with advanced gastric cancer who were refractory to chemotherapy. We determined the HLA genotype of the subjects after enrollment, results of which were held by the evaluation committee and kept from both patients and investigators until completion of the study. The primary end-point was safety of the peptide vaccination. The secondary end-points were immunological responses and clinical outcome, which were compared between the HLA-A*2402-positive and HLA-A*2402-negative groups. The peptides were subcutaneously administered on day 1, 8, 15 and 22 within a 28-day treatment cycle. A total of 14 patients was enrolled in this study; 12 of the 14 patients received 4 or more vaccinations (at least 1 course). No patient had a severe treatment-related adverse event. Findings from evaluation of clinical responses after a single course showed that 4 cases had stable disease and 8 cases had progressive disease. The median overall survival time (MST) for the 12 patients was 3.9 months. The MSTs in the HLA-A*2402-positive and HLA-A*2402-negative groups were, 4.2 and 3.6 months (p= 0.9164), respectively. The results of this study showed that vaccination with URLC10 and VEGFR1 peptides was a safe treatment for advanced gastric cancer. This trial was registered with University Hospital Medical Information Network (UMIN, no. 000002409).
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影响因子：
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