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

基本信息

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
项目类别：
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

项目摘要

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。