Clinical Photodynamic Therapy for Pancreatic and Biliary Tract Cancer

胰腺癌和胆道癌的临床光动力治疗

• 批准号: 8103132
• 负责人: Stephen Pereira
• 金额: $ 21.96万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-09 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8103132
• 关键词: Adjuvant; Biliary; Biliary Tract Cancer; Biopsy; Biopsy Specimen; Carcinoma; Cholangiocarcinoma; Clinical; Clinical Research; Clinical Trials; Computer software; Curative Surgery; Data; Diffuse; Disease Progression; Dose; European Organization for Research and Treatment of Cancer; Excision; Fiber; Fluorescence; Goals; Image; In Situ; Joints; Lead; Life; Light; Location; Malignant Neoplasms; Malignant neoplasm of gallbladder; Malignant neoplasm of pancreas; Maps; Measurement; Measures; Monitor; Necrosis; Neoadjuvant Therapy; Operative Surgical Procedures; Optics; Outcome; Pancreas; Pancreatic carcinoma; Patients; Phase; Photochemotherapy; Photosensitizing Agents; Porfimer Sodium; Principal Investigator; Progression-Free Survivals; Public Health; Quality of life; Randomized; Reaction Time; Resectable; Resected; Retinal Cone; Safety; Site; Societies; Techniques; Testing; Therapeutic; Time; Tissues; Toxic effect; Tumor Burden; Tumor Volume; Unresectable; Validation; Verteporfin; Work; base; biliary tract; chemotherapy; conventional therapy; cost; dosimetry; drug distribution; implantation; improved; light transmission; molecular marker; palliative; palliative chemotherapy; phase 2 study; phase 3 study; programs; prospective; response; safety study; tool; treatment planning; treatment response; tumor; tumor progression

The overall goal of this project is to improve the survival and quality of life of patients with pancreatic and biliary tract carcinoma using photodynamic therapy (PDT). This clinical project involves a number of phase I and III studies using two different photosensitizers (PS), and derives from experimental and early clinical studies of PDT in pancreatic and biliary tract malignancies by our group. In addition, new means for non- invasively measuring PS concentrations and light transmission within tissue will be usedto provide monitoring information that could ultimately be used to manipulate PDT in real time and produce a more effective and uniform therapeutic outcome. The overall theme of the hypotheses tested here is that a reduction in tumor burden can be achieved safely with PDT, and will lead to improvements in survival and quality of life of patients with pancreatic and biliary tract cancer. In Aim 1, following on from our recently completed phase II study of porfimer sodium PDT in biliary tract carcinoma (ETC), a phase III study of palliative PDT plus stenting vs. stenting alone will be performed in patients with locally advanced or metastatic BTC. Aim 2 will test the feasibility and safety of neoadjuvant PDT using porfimer sodium in patients undergoing attempted curative surgical resection of proximal biliary tract carcinoma, with the goal of improving RO resection rates and overall survival. Accurate techniques for dosimetry with photosensitizer and structural treatment planning will also be developed, with the aims of improving PDT dose accuracy and prediction of effect in biliary tract cancer. In Aim 3, in a standard phase I/II dose ranging study using a single fiber followed by a non-randomized phase II multiple fiber study, verteporfin PDT will be administered to patients with locally advanced pancreatic carcinoma to identify the treatment parameters with which to achieve safe and effective tumor necrosis. The results of this study will then be used to inform Aim 4, a randomized phase ll/lll study of verteporfin PDT + standard chemotherapy vs. chemotherapy alone for locally advanced pancreatic cancer. This latter trial will involve full light dose treatment planning with implantation of multiple diffusing fibers into the prescribed volume. The completion of these aims will test the clinical hypotheses that PDT can be successfully incorporated into pancreatobiliary cancer management as a combination approach, either adjuvant or neoadjuvant. Potential benefits to public health: this study with 4 clinical trials could provide new treatments for two cancers, PanCa and BTCwhich currently have few treatment options and are usually fatal putting a heavy burden on society in terms of cost and suffering.

该项目的总体目标是提高胰腺癌患者的生存率和生活质量， 胆道癌的光动力学治疗（PDT）。该临床项目涉及多个阶段 I和III研究使用两种不同的光敏剂（PS），并来自实验和早期临床 我们小组对PDT治疗胰腺和胆道恶性肿瘤的研究。此外，新的手段，为非 将使用侵入性测量组织内的PS浓度和光透射来提供 监测信息，最终可以用来操纵PDT在真实的时间，并产生更多的 有效和一致的治疗结果。这里测试的假设的总体主题是， PDT可以安全地减少肿瘤负荷，并将导致生存率的改善， 胰胆管癌患者的生活质量。在目标1中，继我们最近 完成了porfimer sodium PDT治疗胆道癌（ETC）的II期研究， 姑息性PDT加支架植入术与单纯支架植入术将在局部晚期或 转移性BTC目的2：探讨新辅助光动力疗法（PDT）应用于肿瘤治疗的可行性和安全性。 尝试近端胆道癌根治性手术切除的患者，目标是 提高RO切除率和总生存率。光敏剂剂量测定的精确技术 还将制定结构性治疗计划，目的是提高PDT剂量的准确性， 预测胆道癌的疗效。在目标3中，在标准I/II期剂量范围研究中， 纤维，然后进行非随机II期多纤维研究，将给予维替泊芬PDT， 局部晚期胰腺癌患者，以确定 实现安全有效的肿瘤坏死。这项研究的结果将被用于指导目标4， 维替泊芬PDT +标准化疗与单独化疗的随机II/III期研究 局部晚期胰腺癌后一项试验将涉及全光剂量治疗计划， 将多个扩散纤维植入到规定的体积中。这些目标的实现将考验 PDT可以成功地纳入胰胆管癌治疗的临床假设， 辅助或新辅助的组合方法。对公共卫生的潜在益处：这项研究与 4项临床试验可以为两种癌症提供新的治疗方法，PanCa和BTC，目前几乎没有 治疗选择，通常是致命的，在费用和痛苦方面给社会带来沉重负担。