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: 10484564
• 负责人: Manijeh N Goldberg
• 金额: $ 40.11万
• 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 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484564
• 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; Developed Countries; Disease; Disease remission; Documentation; Dose; Dose-Limiting; Drug Kinetics; Engineering; Enrollment; Ensure; Excision; Exercise; Foundations; Funding; Head; Head and Neck Cancer; Hour; Humidity; Hydrogels; Immune checkpoint inhibitor; Immuno-Chemotherapy; Immunotherapy; Incidence; Income; Infrastructure; Institutional Review Boards; Intravenous; Life; Life Style; Malignant Neoplasms; Mediation; Medical; Methods; Micrometastasis; Modality; Monitor; Nanotechnology; Neoplasm Metastasis; Nodal; Operative Surgical Procedures; Patient Participation; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Plasma; Platinum; Prevalence; Prevention; Privatization; Procedures; Production; Prognostic Factor; Progression-Free Survivals; Protocols documentation; Quality Control; Radiation; Records; Recurrence; Regimen; Research Personnel; Resource-limited setting; Resources; Risk Factors; Safety; Sampling; Site; Solid Neoplasm; Source; Statistical Data Interpretation; Sterilization; Stress; Stress Tests; Survival Rate; Temperature; TimeLine; 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; 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; 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.

项目摘要 口腔癌（OC）是一种服务不足的疾病，经常被医学界忽视。但它是第六大 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。OC每隔一年就有一名美国人丧生 每天的小时。此外，由于口腔人乳头瘤病毒（HPV）的流行率越来越高，它正在上升。 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（如美国）的临床环境中，许多患者接受次优护理， OSCC由于资源有限。虽然靶向剂（即，酪氨酸激酶抑制剂）和免疫疗法（即， 检查点抑制剂）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（特别是）高成本限制了其在美国的低资源使用 在低收入/中等收入国家（LMIC）。晚期OSCC患者的生存率主要由以下因素驱动： 局部治疗失败/复发（即，原发部位或颈淋巴结盆）。常规治疗的升级 由于剂量限制性毒性，诸如手术、放射和全身化疗的方案是不可行的。因此 在这些趋同因素中，需要新的治疗方法，可以增强现有的模式，同时改善 局部区域控制，无毒性。为了满足这一需求，Privo开发了PRV 211术中产品 （PRV 211），一种纳米工程化水凝胶，在肿瘤切除或减积后，可以立即直接应用于 肿瘤床。PRV 211，保留高浓度的免疫/化疗纳米颗粒，局部在肿瘤床中， 局部淋巴结转移，以治疗局部疾病并减少肿瘤复发。