PHASE I -TOPIC 431 - DRUG DELIVERY BY ENDOESOPHAGEAL LAVAGE (EEL) TO TREAT ESOPHAGEAL CANCER

癌症是美国第二大死亡原因，食道癌在所有癌症中存活率最低的第六名。全身药物治疗是广泛转移性食管癌的一线治疗，但受全身毒性、患者资格或费用的限制。专利Isola系统由药物输送导管、管道、加热元件和药物灌洗液组成。一项概念验证动物研究表明，Isola可以直接将药物输送到食管组织，同时当药物溶液在食管腔内输送时，通过使用气球将食管与胃肠道隔离，从而最大限度地减少血浆中的药物含量。目的是治疗食道的癌性肿瘤（腺癌和鳞状细胞癌），同时尽量减少全身药物暴露和毒性。本提案的目标是推进活动，最终完成使用Isola给药系统的首次人体（FIH）研究：a)完成给药系统的设计和选择理想的药物；b)完成装置设计验证和生物相容性测试，以在人体中使用给药系统；c)进行比较慢性动物研究，将Isola给药与标准静脉给药进行比较。

Cancer is the second leading cause of death in the United States and esophageal cancer has the 6th lowest survival rate for all cancers. Systemic drug therapy is first-line therapy for widely metastatic esophageal cancer, but is limited by systemic toxicity, patient eligibility, or cost. The proprietary Isola system consists of a drug delivery catheter, tubing, heating element, and a drug lavage solution. A proof-of concept animal study demonstrated that Isola can deliver drug directly to esophageal tissue while minimizing drug in plasma by using balloons to isolate the esophagus from the gastrointestinal track when a drug solution is delivered in the lumen of the esophagus. The goal of is to treat cancerous tumors (adenocarcinoma and squamous cell carcinoma) in the esophagus while minimizing systemic drug exposure and toxicity. The objective of this proposal is to advance activities to eventually complete a first in human (FIH) study using the Isola drug delivery system by a) finalizing the drug delivery system design and selecting the ideal drug for delivery b) completing device design verification and biocompatibility testing to use drug delivery system in humans and c) conducting comparative chronic animal studies to compare Isola drug delivery to standard intravenous drug delivery.