A phase I dose-escalation clinical trial of intraoperative direct intratumoral injection of HF10 oncolytic virus in non-resectable patients with advanced pancreatic cancer

A phase I dose-escalation clinical trial of intraoperative direct intratumoral injection of HF10 oncolytic virus in non-resectable patients with advanced pancreatic cancer
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DOI:
10.1038/cgt.2010.65
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发表时间:
2011-03-01
影响因子:
6.4
通讯作者:
Nishiyama, Y.
Nishiyama, Y.
中科院分区:
医学3区
文献类型:
--
作者:
Nakao, A.;Kasuya, H.;Nishiyama, Y.

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2005年,我们启动了一项临床试验,检验了溶瘤病毒HF10治疗胰腺癌的疗效。尽管对患者进行多种治疗,但胰腺癌的死亡率仍然很高,迫切需要新的治疗方法。目前癌症治疗的主流方法包括生物疗法,如用于乳腺癌的曲妥珠单抗(Herceptin)或用于非小细胞肺癌的厄洛替尼(Tarceva)。溶瘤病毒治疗是一种新的、有前途的癌症治疗策略。溶瘤病毒是治疗晚期癌症的新型生物疗法,具有广谱的抗癌活性,对人类的毒性最小。为了检验溶瘤病毒治疗胰腺癌的疗效,我们启动了一项先导性研究,向6名不能切除的胰腺癌患者注射三种剂量的HF10。所有患者都被监测了30天的局部和全身不良反应,在此期间没有接受任何其他治疗。没有不良反应,我们根据肿瘤标记物水平、生存期、病理结果和诊断放射学观察到一些治疗潜力。肿瘤分为稳定期3例,部分缓解1例,进展期2例。癌症基因治疗(2011年)18,167 175;doi:10.1038/cgt.2010.65;2010年11月19日在线发布
In 2005, we initiated a clinical trial that examined the efficacy of the oncolytic virus HF10 to treat pancreatic cancer. Pancreatic cancer continues to have a high mortality rate, despite multimodal treatments for patients, and new therapeutic methods are greatly needed. The current mainstream methods for cancer treatment include biological therapeutics such as trastuzumab (Herceptin) for breast cancer or erlotinib (Tarceva) for non-small cell lung cancer. Oncolytic virus therapy is a new and promising treatment strategy for cancer. Oncolytic viruses are novel biological therapeutics for advanced cancer that appear to have a wide spectrum of anticancer activity with minimal human toxicity. To examine the efficacy of oncolytic virus therapy for pancreatic cancer, we initiated pilot studies by injecting six patients with non-resectable pancreatic cancer with three doses of HF10. All patients were monitored for 30 days for local and systemic adverse effects and were not administered any other therapeutics during this period. There were no adverse side-effects, and we observed some therapeutic potential based on tumor marker levels, survival, pathological findings and diagnostic radiography. The tumors were classified as stable disease in three patients, partial response in one patient and progressive disease in two patients. Cancer Gene Therapy (2011) 18, 167 175; doi: 10.1038/cgt.2010.65; published online 19 November 2010