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首页> 外文期刊>Journal of immunotherapy >Phase 1 trial of Wilms tumor 1 (WT1) peptide vaccine and gemcitabine combination therapy in patients with advanced pancreatic or biliary tract cancer.
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Phase 1 trial of Wilms tumor 1 (WT1) peptide vaccine and gemcitabine combination therapy in patients with advanced pancreatic or biliary tract cancer.

机译：Wilms肿瘤1（WT1）肽疫苗和吉西他滨联合疗法在晚期胰腺癌或胆道癌患者中的1期试验。

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An open-labeled, dose-escalation phase 1 trial of Wilms tumor 1 (WT1) vaccine and gemcitabine (GEM) combination therapy for patients with advanced pancreatic cancer or biliary tract cancer was performed. The primary end point was evaluation of toxicity, safety, and optimal immunologic dose of vaccine. Human leukocyte antigen (HLA)-A 0201, HLA-A 0206, and/or HLA-A 2402-positive patients with inoperable advanced pancreatic or biliary tract cancer who had not previously been treated with GEM were eligible for this study. Six doses of GEM and 4 doses of WT1 peptide (1 or 3 mg) emulsified in Montanide adjuvant were administered over 2 months. Twenty-five patients (13 male and 12 female) were enrolled. Nine patients had inoperable advanced pancreatic cancer, 8 had gallbladder cancer, 4 had intrahepatic, and 4 had extrahepatic bile duct cancer. The adverse events were comparable to those with GEM alone. Delayed-type hypersensitivity test was positive after vaccination in 2 patients, and WT1-specific T cells in peptide-stimulated culture were detected by tetramer assay in 59% (13 of 22) of patients. The disease control rate at 2 months was 89% for pancreatic cancer and 50% for biliary tract cancer. With a median follow-up time of 259 days, the median survival time for biliary tract cancer was 288 days, and that for pancreatic cancer was 259 days. Although objective clinical efficacy was not apparent, the safety of WT1 vaccine and GEM combination therapy was confirmed in this study.
机译：进行了一项公开标签，剂量递增的Wilms肿瘤1（WT1）疫苗和吉西他滨（GEM）联合疗法治疗晚期胰腺癌或胆道癌患者的研究。主要终点是评估疫苗的毒性，安全性和最佳免疫剂量。先前未接受GEM治疗的患有无法手术的晚期胰腺癌或胆道癌的人白细胞抗原（HLA）-A 0201，HLA-A 0206和/或HLA-A 2402阳性患者有资格参加本研究。在2个月内给予在Montanide佐剂中乳化的6剂GEM和4剂WT1肽（1或3 mg）。入组患者25例（男13例，女12例）。 9例无法手术的晚期胰腺癌，8例胆囊癌，4例肝内癌，4例肝外胆管癌。不良事件与单独使用GEM的事件相当。疫苗接种后的迟发型超敏反应试验阳性的2例患者，并且通过四聚体测定法在59％（22例中的13例）患者中检测了肽刺激培养物中的WT1特异性T细胞。胰腺癌2个月时的疾病控制率为89％，胆管癌为50％。中位随访时间为259天，胆道癌的中位生存时间为288天，胰腺癌的中位生存时间为259天。尽管客观的临床疗效尚不明确，但该研究证实了WT1疫苗和GEM联合疗法的安全性。

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