Prospective Evaluation of Artificial Intelligence R&D tool for patient stratification in Pancreatic and Liver cancers (PEAR-PAL)

肝细胞癌(HCC)和胰腺导管腺癌(PDAC)是两种最具挑战性的胃肠道疾病。肝癌和胰腺癌分别是所有肝癌和胰腺癌中预后最差的，由于缺乏有效的、有针对性的治疗方法和将患者与正确的治疗流程相匹配的手段，术后两年的复发率分别超过80%和95%。Pear Bio开发了一种芯片上器官技术和计算机视觉流水线，通过它可以在患者的肿瘤上同时测试各种治疗方案。这项技术包括一个微型系统，用于模拟人类肿瘤并在实验室模拟癌症行为(芯片上的器官)，结合使用人类癌细胞、水凝胶、微流体和图像分析。有了这一点，Pear Bio能够在患者自身的肿瘤体外测试不同的治疗方法，预测哪种治疗方法对特定患者更有益，哪些治疗无效。这项创新技术代表着个性化癌症护理的突破，帮助肿瘤学家避免对患者没有好处的治疗，从而将不必要的副作用降至最低，改善患者结果和生存可能性，并节省NHS的关键资源和支出。通过PEAR-PAL，Pear Bio旨在将该工具的临床应用扩展到高需求的癌症，即晚期胰腺癌和肝癌。我们将与国王学院医院合作，以获取新鲜的PDAC和肝细胞癌患者样本。样品将在Pear Bio专有的单芯片器官技术中培养，并在Pear Bio测试(5天)中针对各种处理方案进行测试。多个指标被测量和可视化，包括细胞存活率、肿瘤的缩小/生长、细胞迁移和速度。这些数据被汇编成一份报告，使肿瘤学家能够权衡治疗方案，并继续进行有效的治疗。与伦敦IVD公司的合作将使Pear Bio公司能够对Pear Bio公司进入市场的测试路线、商业化战略、健康经济学以及患者和公众参与进行全面评估。由于这项研究是非干预性的，患者的安全、健康或治疗选择不会受到影响。在该项目结束时，将利用进一步的合作来进行临床试验，以获得监管部门对胰腺癌和肝癌诊断测试的批准。在未来的研究中，Pear Bio的测试将在治疗开始之前作为一种治疗选择工具进行，旨在指导肿瘤学家为任何给定的患者选择方案。

Hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC) are two of the most challenging gastrointestinal diseases to treat. HCC and PDAC have the worst outcome of all liver and pancreatic cancers respectively, with over 80% and 95% 2-year recurrence (cancer coming back) after surgery, owing to a lack of efficient, targeted treatments and means of matching patients with the correct stream of treatment.Pear Bio have developed an organ-on-a-chip technology and computer vision pipeline through which various therapeutic regimens can be tested simultaneously on patient tumours. This technology consists of a micro-scale system used for mimicking human tumours and model cancer behaviour in the lab (organ-on-a-chip), combining the use of human cancer cells, hydrogels, microfluidics and image analysis. With this, Pear Bio is able to test different treatments on a patient's own tumour, outside of their body, predicting which one is going to be more beneficial for that specific patient, and which ones are ineffective. This innovative technology represents a breakthrough in personalised cancer care, helping oncologists avoid treatments that provide patients with no benefit, thus minimising unnecessary side effects, improving patient outcomes and likelihood of survival, and saving the NHS critical resources and expenditure.With PEAR-PAL, Pear Bio aims to expand the tool's clinical utility to high unmet need cancers, namely advanced pancreatic and liver. We will be collaborating with King's College Hospital in order to source fresh PDAC and HCC patient samples. Samples will be cultured in Pear Bio's proprietary organ-on-a-chip technology and tested against various treatment regimes in the Pear Bio test (5 days). Multiple metrics are measured and visualised, including cell viability, the shrinking/growth of the tumour, cell migration and speed. This data is compiled into a report that will allow an oncologist to weigh treatment options and proceed with an effective treatment. Collaboration with London IVD will enable a comprehensive assessment of Pear Bio's test route to market, commercialisation strategy, health economics as well as patient and public engagement.As this study is non-interventional, patient safety, health or choice of treatment will not be affected. At the conclusion of this project, further collaborations will be used to run clinical trials for regulatory approval of the diagnostic test in pancreatic and liver cancers. In future studies, Pear Bio's test will be run prior to the start of therapy as a treatment selection tool, aiming to guide oncologists in their choice of regimen for any given patient.