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

提高资源匮乏地区口腔癌患者生存率的临床研究

• 批准号: 10807196
• 负责人: Manijeh N Goldberg
• 金额: $ 98.73万
• 依托单位: PRIVO TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10807196
• 关键词: Address; American; Animals; Appearance; Area; Awareness; Beds; Biological Assay; Biometry; Blood; Budgets; Cancer Patient; Cancerous; Case Report Form; Cells; Cervical; Cisplatin; Clinical; Clinical Research; Clinical Trials; Communities; Contracts; Country; Coupled; Data; Data Analyses; Developed Countries; Disease; Disease remission; Documentation; Dose; Dose Limiting; Drug Kinetics; Electronics; Eligibility Determination; Engineering; Enrollment; Ensure; Excision; Exercise; Foundations; Funding; Head; Head and Neck Cancer; Hour; Humidity; Hydrogels; Immune checkpoint inhibitor; Immunotherapy; Incidence; Income; Infrastructure; Institutional Review Boards; Intravenous; Life; Life Style; Malignant Neoplasms; Mediation; Medical; Metastatic Neoplasm to Lymph Nodes; Methods; Micrometastasis; Modality; Monitor; Nanotechnology; Nodal; Operative Surgical Procedures; Outsourcing; Patient Participation; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Plasma; Platinum; Prevalence; Prevention; Privatization; Procedures; Production; Prognostic Factor; Progression-Free Survivals; Protocols documentation; Quality Control; RTN4 gene; Radiation; Records; Recurrence; Recurrent tumor; Regimen; Research Personnel; Resource-limited setting; Resources; Risk Factors; Safety; Sampling; Site; Solid Neoplasm; Source; Squamous cell carcinoma; Statistical Data Interpretation; Sterilization; Stress; Stress Tests; Survival Rate; Temperature; Toxic effect; Treatment Failure; Treatment Protocols; Treatment-related toxicity; Tumor Debulking; Tyrosine Kinase Inhibitor; United States; Viscosity; Visit; Whole Blood; aggressive therapy; cancer cell; cancer risk; chemotherapeutic agent; chemotherapy; clinical trial analysis; conventional therapy; cost; data management; design; disorder control; draining lymph node; electronic data; electronic data capture system; experience; follow-up; immunoregulation; improved; lymph nodes; malignant mouth neoplasm; manufacture; mass spectrometer; microbial; mouth squamous cell carcinoma; nanoengineering; nanoparticle; novel; operation; oral HPV; oral care; outreach; oxidation; patient population; phase 2 study; photolysis; prevent; response; side effect; socioeconomics; stability testing; targeted agent; therapeutic nanoparticles; timeline; tool; tumor

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.

项目概要 口腔癌（OC）是一种治疗不足的疾病，经常被医学界忽视。但它却排在第六位 世界上常见且最致命的癌症。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) - 头颈癌的常见亚型。 OC 每夺走一名美国人的生命 每天的一小时。此外，由于口腔人乳头状瘤病毒（HPV）的患病率不断增加，这一数字还在上升。 总体而言，OC 在 5 年缓解目标后的生存率为 60%，复发是一个重要的预后因素。 数据显示，OC 风险与低社会经济水平以及与生活方式相关的风险因素之间存在高度相关性。即使在 在工业化国家（例如美国）的临床环境中，许多患者接受的护理并不理想 OSCC 由于资源有限。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）已在多种实体瘤类型中显示出前景，它们在晚期 OSCC 中的适用性 仍然值得怀疑。不可预测的副作用、并发症和（尤其是）高成本限制了它们在美国资源匮乏的情况下的使用 环境和低/中等收入国家 (LMIC)。晚期 OSCC 患者的生存率主要取决于 局部治疗失败/复发（即原发部位或颈淋巴结盆地）。常规治疗升级 由于剂量限制性毒性，手术、放疗和全身化疗等治疗方案不可行。因此 在这些汇聚因素中，需要新的治疗方法来增强现有的治疗方式，同时改善 局部控制无毒性。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，在肿瘤切除或减灭后立即可以直接应用于 肿瘤床。 PRV211，在肿瘤床局部保留高浓度的免疫/化疗纳米粒子， 区域淋巴结治疗局部疾病并减少肿瘤复发。