Clinical Studies for Improving Survival Rates for Oral Cancer Patients in Low Resource Settings

项目摘要 口腔癌(OC)是一种未得到充分治疗的疾病，常常被医学界忽视。然而，它是世界上第六大 世界上最常见和最致命的癌症。根据口腔癌基金会的数据，超过90%的口腔癌是口腔癌 鳞状细胞癌(OSCC)--头颈部癌症的常见亚型。奥委会每夺走一名美国人的生命 每天的一小时。此外，由于口腔人乳头瘤病毒(HPV)的日益流行，它正在上升。 总体而言，OC在5年缓解目标后有60%的存活率，复发是一个重要的预后因素。 数据显示，OC风险与低社会经济以及与生活方式相关的风险因素具有很高的相关性。即使是在 在工业化国家的临床环境中，如美国，许多患者接受的治疗不是最理想的 由于资源有限，OSCC。尽管靶向药物(即，酪氨酸激酶抑制剂)和免疫疗法(即， 检查点抑制剂)已经在多种实体肿瘤类型中显示出希望，它们在晚期口腔鳞癌的设置中的适用性 仍然值得怀疑。不可预测的副作用、并发症和(特别是)高成本限制了它们在美国的低资源使用 在环境和低/中等收入国家(LMIC)。晚期口腔鳞状细胞癌患者的生存主要是由 局部治疗失败/复发(即原发部位或颈部淋巴结盆地)。常规治疗升级 由于剂量限制的毒性，手术、放疗和全身化疗等方案是不可行的。结果 在这些汇聚的因素中，需要新的治疗方法来增强现有的模式，同时改善 无毒副作用的局部区域控制。为了满足这一需求，Privo开发了PRV211术中产品 (PRV211)，一种纳米工程水凝胶，在肿瘤切除或去瘤后立即可以直接涂在 肿瘤病床。PRV211，在肿瘤床和局部保留高浓度的免疫/化疗纳米粒 区域淋巴结治疗局部区域疾病，减少肿瘤复发。

Project Summary Oral cancer (OC) is an underserved disease, which is often overlooked by the medical community. Yet it is the 6th most common and deadliest cancer in the world. According to the Oral Cancer Foundation, over 90% of all oral cancers are oral squamous cell carcinoma (OSCC) - a common subset of head and neck cancers. OC claims the life of one American every hour of each day. Additionally, it is on the rise due to the increasing prevalence of oral human papilloma virus (HPV). Overall, OC has a 60% survival rate after 5-year remission target, with recurrence being an important prognostic factor. Data shows a high correlation between OC risks and low socioeconomic, as well as risk factors related to lifestyle. Even in the clinical settings of industrialized nations, such as the United States (US), many patients receive suboptimal care for OSCC due to limited resources. Although targeted agents (i.e., tyrosine kinase inhibitors) and immunotherapy (i.e., checkpoint inhibitors) have shown promise in multiple solid tumor types, their applicability in the setting of advanced OSCC remains questionable. Unpredictable side effects, complications, and (especially) high cost limit their US use in low resource settings and in low/mid-income countries (LMICs). Survival in patients with advanced OSCC is driven primarily by locoregional treatment failure/recurrence (i.e., primary site or cervical nodal basins). Escalation of conventional treatment regimens, such as surgery, radiation, and systemic chemotherapy is not feasible due to dose-limiting toxicities. As a result of these converging factors, there is a need for novel treatments that can augment existing modalities, while improving locoregional control without toxicities. To address this need, Privo has developed the PRV211 intraoperative product (PRV211), a nano-engineered hydrogel that, immediately after tumor resection or debulking, can be applied directly onto the tumor bed. PRV211, retains high concentration of immuno/chemotherapy nanoparticles, locally in tumor bed and regional lymph nodes to treat the locoregional disease and reduce tumor recurrence.