Department of Advanced Cell and Molecular Therapy, Kyushu University Hospital, Fukuoka, Japan.
Division of Oncology, Research Center for Medical Sciences, The Jikei University School of Medicine, Tokyo, Japan.
Anticancer Res. 2021 Mar;41(3):1485-1496. doi: 10.21873/anticanres.14907.
As the prognosis of biliary tract cancer (BTC) is extremely poor and treatment options are limited, new treatment modalities are urgently needed. We designed a phase II clinical trial to investigate the immune responses and clinical benefits of OCV-C01, an HLA-A*24:02-restricted three-peptide cancer vaccine targeting VEGFR1, VEGFR2, and KIF20A.
Participants were patients with advanced BTC who had unresectable tumours and were refractory to standard chemotherapy. OCV-C01 was injected weekly until the discontinuance criteria were met.
Six participants, including four patients positive for HLA-A*24:02, were enrolled in this study for assessment of efficacy. Four out of six patients exhibited vaccine-specific T-cell responses to one or more of three antigens. Log-rank tests revealed that vaccine-specific T cell responses contributed significantly to overall survival.
The cancer vaccine had positive effects on survival, indicating that this approach warrants further clinical studies.
由于胆道癌（BTC）的预后极差，且治疗选择有限，因此迫切需要新的治疗方式。我们设计了一项 II 期临床试验，以研究 OCV-C01 的免疫反应和临床获益，这是一种针对 VEGFR1、VEGFR2 和 KIF20A 的 HLA-A*24:02 限制性三肽癌症疫苗。
参与者为患有不可切除肿瘤且对标准化疗耐药的晚期 BTC 患者。OCV-C01 每周注射一次，直到达到停药标准。
本研究共纳入 6 名 HLA-A*24:02 阳性的患者，以评估疗效。6 名患者中有 4 名对三种抗原中的一种或多种表现出疫苗特异性 T 细胞反应。对数秩检验显示，疫苗特异性 T 细胞反应对总生存期有显著影响。
癌症疫苗对生存有积极影响，表明这种方法值得进一步的临床研究。
